Prescription drug · ANDA
Clindamycin Hydrochloride NDC 68071-3582
Clindamycin hydrochloride 150 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3582-1 | 68071358201 | 21 CAPSULE in 1 BOTTLE (68071-3582-1)Marketed from Apr 25, 2025 | |
| 68071-3582-3 | 68071358203 | 30 CAPSULE in 1 BOTTLE (68071-3582-3)Marketed from Mar 4, 2024 | |
| 68071-3582-4 | 68071358204 | 14 CAPSULE in 1 BOTTLE (68071-3582-4)Marketed from Jan 28, 2025 | |
| 68071-3582-6 | 68071358206 | 60 CAPSULE in 1 BOTTLE (68071-3582-6)Marketed from Nov 8, 2024 | |
| 68071-3582-7 | 68071358207 | 40 CAPSULE in 1 BOTTLE (68071-3582-7)Marketed from Feb 13, 2025 |
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 — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 68071-3582_33a14d92-da84-996c-e063-6394a90ae3b8SPL ID 33a14d92-da84-996c-e063-6394a90ae3b8SPL set ID 12dea490-e179-f295-e063-6394a90af4aaRxCUI 197518UNII T20OQ1YN1WUPC 0368071358230
- 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
N468071358201followed by a unit qualifier and the quantityPackage 68071-3582-01. 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 . 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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