Prescription drug · ANDA
Clindamycin Hydrochloride NDC 82804-278
Clindamycin hydrochloride 300 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-278-21 | 82804027821 | 21 CAPSULE in 1 BOTTLE (82804-278-21)Marketed from Apr 9, 2026 | |
| 82804-278-30 | 82804027830 | 30 CAPSULE in 1 BOTTLE (82804-278-30)Marketed from Apr 9, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Clindamycin Hydrochloride
- Generic name (nonproprietary)
- clindamycin hydrochloride
- Active ingredients
- Clindamycin hydrochloride — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216957
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 82804-278_d2e4a66b-21ee-4bbd-9086-9485e5cf29d5SPL ID d2e4a66b-21ee-4bbd-9086-9485e5cf29d5SPL set ID d1aa1e91-4ac8-40d1-9fc4-963e1c9c3278RxCUI 284215UNII T20OQ1YN1WUPC 0382804278305
- 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
N482804027821followed by a unit qualifier and the quantityPackage 82804-0278-21. 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 su…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216957
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 Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Redpharm Drug | 67296-2149 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Coupler LLC | 67046-2073 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2623 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7354 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3772 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7374 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Sportpharm LLC | 85766-028 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7669 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8558 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3657 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-143 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 75 mg/1 | CapsuleOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-142 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-144 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Brisk Pharmaceuticals | 73614-204 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2432 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3681 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-827 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-828 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3983 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4353 |
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