Cefadroxil how supplied: Difference between revisions

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__NOTOC__
__NOTOC__
{{Cefadroxil}}
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{{CMG}}; {{AE}} {{SS}}


==How Supplied==
==How Supplied==
Cefadroxil For Oral Suspension, USP is available in:
The 125 mg per 5 mL of reconstituted suspension* contains cefadroxil monohydrate equivalent to 125 mg with a light orange colored powder forming orange suspension on constitution with water. The resulting suspension has a characteristic mixed fruit flavor and is available as follows:
* NDC 63304-972-04 100 mL bottles
The 250 mg per 5 mL of reconstituted suspension* contains cefadroxil monohydrate equivalent to 250 mg with a light orange colored powder forming orange suspension on constitution with water. The resulting suspension has a characteristic mixed fruit flavor and is available as follows:
* NDC 63304-973-03 50 mL bottles
* NDC 63304-973-04 100 mL bottles
The 500 mg per 5 mL of reconstituted suspension* contains cefadroxil monohydrate equivalent to 500 mg with a light orange colored powder forming orange suspension on constitution with water. The resulting suspension has a characteristic mixed fruit flavor and is available as follows:
* NDC 63304-974-01 75 mL bottles
* NDC 63304-974-04 100 mL bottles
: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. After reconstitution, store in refrigerator. Any unused portion of the reconstituted suspension must be discarded after 14 days.
Prior to reconstitution: Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature).
DURICEF® (cefadroxil monohydrate, USP) 500 mg Capsules: opaque, maroon and white hard gelatin capsules, imprinted with “PPP’’ and “784’’ on one end and with “DURICEF’’ and “500 mg’’ on the other end.
DURICEF® (cefadroxil monohydrate, USP) 500 mg Capsules: opaque, maroon and white hard gelatin capsules, imprinted with “PPP’’ and “784’’ on one end and with “DURICEF’’ and “500 mg’’ on the other end.


Capsules are supplied as follows:
Capsules are supplied as follows:


N 0430-0780-19 Bottle of 50
* N 0430-0780-19 Bottle of 50


Store at controlled room temperature 15°–30° C (59°–86° F).
Store at controlled room temperature 15°–30° C (59°–86° F).
Line 14: Line 37:
DURICEF® 1 gram Tablets: white to off white, top bisected, oval shaped, imprinted with “PPP’’ on one side of the bisect and “785’’ on the other side of the bisect. Tablets are supplied as follows:
DURICEF® 1 gram Tablets: white to off white, top bisected, oval shaped, imprinted with “PPP’’ on one side of the bisect and “785’’ on the other side of the bisect. Tablets are supplied as follows:


N 0430-0781-19 Bottle of 50
* N 0430-0781-19 Bottle of 50


Store at controlled room temperature 15°–30° C (59°–86° F).
Store at controlled room temperature 15°–30° C (59°–86° F).
Line 22: Line 45:
250 mg/5 mL N 0430-2782-15  50 mL Bottle
250 mg/5 mL N 0430-2782-15  50 mL Bottle


N 0430-2782-17 100 mL Bottle
* N 0430-2782-17 100 mL Bottle


500 mg/5 mL N 0430-2783-16  75 mL Bottle
500 mg/5 mL N 0430-2783-16  75 mL Bottle


N 0430-2783-17 100 mL Bottle
* N 0430-2783-17 100 mL Bottle


Prior to reconstitution: Store at controlled room temperature 15°–30° C (59°–86° F).<ref>{{Cite web | last = |first = |title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf |publisher = |date = | accessdate = }}</ref>
Prior to reconstitution: Store at controlled room temperature 15°–30° C (59°–86° F).<ref>{{Cite web | last = |first = |title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf |publisher = |date = | accessdate = }}</ref>
==References==
==References==
{{Reflist}}
{{Reflist}}

Latest revision as of 23:34, 5 January 2014

Cefadroxil
DURICEF® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

How Supplied

Cefadroxil For Oral Suspension, USP is available in:

The 125 mg per 5 mL of reconstituted suspension* contains cefadroxil monohydrate equivalent to 125 mg with a light orange colored powder forming orange suspension on constitution with water. The resulting suspension has a characteristic mixed fruit flavor and is available as follows:

  • NDC 63304-972-04 100 mL bottles

The 250 mg per 5 mL of reconstituted suspension* contains cefadroxil monohydrate equivalent to 250 mg with a light orange colored powder forming orange suspension on constitution with water. The resulting suspension has a characteristic mixed fruit flavor and is available as follows:

  • NDC 63304-973-03 50 mL bottles
  • NDC 63304-973-04 100 mL bottles

The 500 mg per 5 mL of reconstituted suspension* contains cefadroxil monohydrate equivalent to 500 mg with a light orange colored powder forming orange suspension on constitution with water. The resulting suspension has a characteristic mixed fruit flavor and is available as follows:

  • NDC 63304-974-01 75 mL bottles
  • NDC 63304-974-04 100 mL bottles
SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. After reconstitution, store in refrigerator. Any unused portion of the reconstituted suspension must be discarded after 14 days.

Prior to reconstitution: Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature).

DURICEF® (cefadroxil monohydrate, USP) 500 mg Capsules: opaque, maroon and white hard gelatin capsules, imprinted with “PPP’’ and “784’’ on one end and with “DURICEF’’ and “500 mg’’ on the other end.

Capsules are supplied as follows:

  • N 0430-0780-19 Bottle of 50

Store at controlled room temperature 15°–30° C (59°–86° F).

DURICEF® 1 gram Tablets: white to off white, top bisected, oval shaped, imprinted with “PPP’’ on one side of the bisect and “785’’ on the other side of the bisect. Tablets are supplied as follows:

  • N 0430-0781-19 Bottle of 50

Store at controlled room temperature 15°–30° C (59°–86° F).

DURICEF® for Oral Suspension is orange-pineapple flavored, and is supplied as follows:

250 mg/5 mL N 0430-2782-15 50 mL Bottle

  • N 0430-2782-17 100 mL Bottle

500 mg/5 mL N 0430-2783-16 75 mL Bottle

  • N 0430-2783-17 100 mL Bottle

Prior to reconstitution: Store at controlled room temperature 15°–30° C (59°–86° F).[1]

References

  1. ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf" (PDF). External link in |title= (help)

Adapted from the FDA Package Insert.

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