Prescription drug · NDA
Cleocin (clindamycin phosphate) NDC 0009-7667
Clindamycin phosphate 100 mg/1 · Suppository · Vaginal · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-7667-05 | 00009766705 | 1 BLISTER PACK in 1 CARTON (0009-7667-05) / 3 SUPPOSITORY in 1 BLISTER PACKMarketed from Feb 3, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Cleocin
- Generic name (nonproprietary)
- clindamycin phosphate
- Active ingredients
- Clindamycin phosphate — 100 mg/1
- Dosage form
- Suppository
- Route
- Vaginal
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050767
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 0009-7667_187697a2-a941-4fe8-9be2-c442d0fd5e07SPL ID 187697a2-a941-4fe8-9be2-c442d0fd5e07SPL set ID 3db26227-208d-4fdd-8426-1d9be5cda9b4RxCUI 259233, 882533UNII 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
N400009766705followed by a unit qualifier and the quantityPackage 00009-7667-05. 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 CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. 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 clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnere…
Excerpt only. Read the full label for complete information.