Prescription drug · ANDA
Clindamycin Hydrochloride NDC 62135-766
Clindamycin hydrochloride 300 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-766-01 | 6213507660162135076601 | 100 CAPSULE in 1 BOTTLE (62135-766-01)Marketed from Jan 12, 2024 |
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
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065243
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 62135-766_0f266520-6156-ae80-e063-6394a90a8dc6SPL ID 0f266520-6156-ae80-e063-6394a90a8dc6SPL set ID e8167412-882e-4143-93c6-49e68adbcf16RxCUI 197518, 284215, 309329UNII T20OQ1YN1WUPC 0362135766016, 0362135764012, 0362135765019
- 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
N462135076601followed by a unit qualifier and the quantityPackage 62135-0766-01. 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 s…
Excerpt only. Read the full label for complete information.
About NDC 62135-766
- What is NDC 62135-766?
- 62135-766 is the product NDC for Clindamycin Hydrochloride, Clindamycin hydrochloride 300 mg/1 capsule, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 065243
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 75 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-764 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 150 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-765 |