NDC codes

FDA NDC Directory
Product NDC (as listed)59762-5009Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59762-5009Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
59762-5009-1597625009011 TUBE in 1 CARTON (59762-5009-1) / 40 g in 1 TUBEMarketed from Aug 11, 1992

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
clindamycin phosphate
Generic name (nonproprietary)
clindamycin phosphate
Active ingredients
Clindamycin phosphate — 20 mg/g
Dosage form
Cream
Route
Vaginal
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 050680
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 59762-5009_ce0c0769-0851-485c-b5eb-30da2fa3484cSPL ID ce0c0769-0851-485c-b5eb-30da2fa3484cSPL set ID b52bdaf7-3b54-4165-9ab0-9dfa08170e47RxCUI 309337UNII EH6D7113I8
Pharmacologic class
Lincosamide Antibacterial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N459762500901 followed by a unit qualifier and the quantity

Package 59762-5009-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES .) NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050680

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 050680
ProductStrengthForm · routeLabelerProduct NDC
Cleocinclindamycin phosphateClindamycin phosphate 20 mg/gCreamVaginalPharmacia & Upjohn Company LLC0009-3448

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