Prescription drug · ANDA
Clindamycin Hydrochloride NDC 63187-127
Clindamycin hydrochloride 300 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-127-20 | 63187012720 | 20 CAPSULE in 1 BOTTLE (63187-127-20)Marketed from Nov 4, 2020 | |
| 63187-127-21 | 63187012721 | 21 CAPSULE in 1 BOTTLE (63187-127-21)Marketed from Jul 1, 2014 | |
| 63187-127-28 | 63187012728 | 28 CAPSULE in 1 BOTTLE (63187-127-28)Marketed from Nov 17, 2020 | |
| 63187-127-30 | 63187012730 | 30 CAPSULE in 1 BOTTLE (63187-127-30)Marketed from Nov 4, 2020 | |
| 63187-127-40 | 63187012740 | 40 CAPSULE in 1 BOTTLE (63187-127-40)Marketed from Jan 5, 2021 | |
| 63187-127-60 | 63187012760 | 60 CAPSULE in 1 BOTTLE (63187-127-60)Marketed from Nov 4, 2020 | |
| 63187-127-90 | 63187012790 | 90 CAPSULE in 1 BOTTLE (63187-127-90)Marketed from Nov 4, 2020 |
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 065442
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4SPL ID 146abd0d-3e2b-480f-a2f0-925e9c36cec4SPL set ID d6e1a5f2-9dcb-49fb-a5b0-d7d543520ac3RxCUI 284215UNII T20OQ1YN1WUPC 0363187127305
- 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
N463187012720followed by a unit qualifier and the quantityPackage 63187-0127-20. 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 seri‑ous 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 WARNING box, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythrom…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065442
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 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-185 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-186 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7659 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | VERITYRX, LLC | 83939-0019 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-317 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Redpharm Drug | 67296-0940 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3907 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7194 |
| Clindamycin HCL | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0145 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0443 |