Prescription drug · ANDA
Clindamycin Hydrochloride NDC 65862-185
Clindamycin hydrochloride 150 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-185-01 | 6586201850165862018501 | 100 CAPSULE in 1 BOTTLE (65862-185-01)Marketed from Aug 26, 2009 | |
| 65862-185-05 | 6586201850565862018505 | 500 CAPSULE in 1 BOTTLE (65862-185-05)Marketed from Aug 26, 2009 |
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 — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- 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 65862-185_b7173baa-2b39-4c31-82d4-839ac362e190SPL ID b7173baa-2b39-4c31-82d4-839ac362e190
- 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
N465862018501followed by a unit qualifier and the quantityPackage 65862-0185-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 65862-185
- What is NDC 65862-185?
- 65862-185 is the product NDC for Clindamycin Hydrochloride, Clindamycin hydrochloride 150 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin Hydrochloride.
- What is the active ingredient?
- Clindamycin hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clindamycin Hydrochloride?
- 88 other product NDCs are listed under this name. See all Clindamycin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-005 | 87441-0005-01 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Coupler LLC | 67046-2073 | 67046-2073-03 |
| Clindamycin hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4583 | 70518-4583-0070518-4583-01 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4353 | 70518-4353-00 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-828 | 60760-0828-2860760-0828-60 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0416 | 80425-0416-0180425-0416-0280425-0416-03 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-827 | 60760-0827-1060760-0827-30 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8685 | 68788-8685-0168788-8685-0268788-8685-03+4 more |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8558 | 68788-8558-0068788-8558-0168788-8558-02+5 more |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3772 | 70518-3772-0070518-3772-0170518-3772-02+3 more |
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 HCL | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0145 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7194 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0443 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3907 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7659 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-317 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Proficient Rx LP | 63187-127 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Redpharm Drug | 67296-0940 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | VERITYRX, LLC | 83939-0019 |