Prescription drug · ANDA
Clindamycin hydrochloride NDC 85534-0087
Clindamycin hydrochloride 150 mg/1 · Capsule · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0087-0 | 85534008700 | 8 CAPSULE in 1 BOTTLE (85534-0087-0)Marketed from Jul 18, 2026 | |
| 85534-0087-1 | 85534008701 | 12 CAPSULE in 1 BOTTLE (85534-0087-1)Marketed from Jul 18, 2026 | |
| 85534-0087-2 | 85534008702 | 20 CAPSULE in 1 BOTTLE (85534-0087-2)Marketed from Jul 18, 2026 | |
| 85534-0087-3 | 85534008703 | 28 CAPSULE in 1 BOTTLE (85534-0087-3)Marketed from Jul 18, 2026 | |
| 85534-0087-4 | 85534008704 | 30 CAPSULE in 1 BOTTLE (85534-0087-4)Marketed from Jul 18, 2026 | |
| 85534-0087-5 | 85534008705 | 40 CAPSULE in 1 BOTTLE (85534-0087-5)Marketed from Jul 18, 2026 |
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
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065061
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 85534-0087_56dce2d7-c4ea-2e79-e063-6394a90af558SPL ID 56dce2d7-c4ea-2e79-e063-6394a90af558SPL set ID c6703df0-b41d-439f-8e0d-d30b3039b3f8RxCUI 197518, 284215UNII T20OQ1YN1W
- 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
N485534008700followed by a unit qualifier and the quantityPackage 85534-0087-00. 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 hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are 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., erythr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065061
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 | Bryant Ranch Prepack | 71335-0320 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0088 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-005 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | American Health Packaging | 68084-243 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | American Health Packaging | 68084-244 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Proficient Rx LP | 63187-247 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1985 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-5959 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0967 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3939 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 63304-692 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 63304-693 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-373 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4583 |
| Clindamycin HCL | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0103 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-207 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0200 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4257 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Proficient Rx LP | 63187-141 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-7276 |
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