Prescription drug · NDA
Cleocin (Clindamycin phosphate) NDC 0009-3448
Clindamycin phosphate 20 mg/g · Cream · Vaginal · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-3448-01 | 0000934480100009344801 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0009-3448-01) / 40 g in 1 TUBE, WITH APPLICATORMarketed from Aug 11, 1992 |
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 — 20 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Pharmacia & Upjohn Company LLCNDC labeler code 0009
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication 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 0009-3448_08bcc2dc-71ea-4664-89e8-73d6a3a01322SPL ID 08bcc2dc-71ea-4664-89e8-73d6a3a01322SPL set ID f9be442d-0782-4b93-828f-9ebbf67dbcedRxCUI 309337, 882536UNII 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
N400009344801followed by a unit qualifier and the quantityPackage 00009-3448-01. 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 CLEOCIN 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). CLEOCIN 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 clue cells on microscopic e…
Excerpt only. Read the full label for complete information.
About NDC 0009-3448
- What is NDC 0009-3448?
- 0009-3448 is the product NDC for Cleocin (clindamycin phosphate), Clindamycin phosphate 20 mg/g cream, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cleocin (Clindamycin phosphate).
- What is the active ingredient?
- Clindamycin phosphate.
- Who is the labeler?
- Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cleocin?
- 1 other product NDC are listed under this name. See all Cleocin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cleocin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cleocinclindamycin phosphate | Clindamycin phosphate 100 mg/1 | SuppositoryVaginal | Pharmacia & Upjohn Company LLC | 0009-7667 | 00009-7667-05 |
Other NDCs under NDA 050680
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| clindamycin phosphate | Clindamycin phosphate 20 mg/g | CreamVaginal | Mylan Pharmaceuticals Inc. | 59762-5009 |