Prescription drug · ANDA
clindamycin hydrochloride NDC 69238-2121
Clindamycin hydrochloride 300 mg/1 · Capsule, Gelatin coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2121-3 | 69238212103 | 3 BLISTER PACK in 1 CARTON (69238-2121-3) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69238-2121-4)Marketed from Apr 25, 2022 |
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 hydrochloride
- Generic name (nonproprietary)
- clindamycin hydrochloride
- Active ingredients
- Clindamycin hydrochloride — 300 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065194
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 69238-2121_f118e287-5acc-4a8b-bcf0-01436de5bdf9SPL ID f118e287-5acc-4a8b-bcf0-01436de5bdf9SPL set ID e08eea9e-464c-429e-9584-b768f5127767RxCUI 284215UNII T20OQ1YN1WUPC 0369238212136
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469238212103followed by a unit qualifier and the quantityPackage 69238-2121-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections s…
Excerpt only. Read the full label for complete information.