Prescription drug · ANDA
Clindamycin HCL NDC 80425-0145
Clindamycin hydrochloride 300 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0145-1 | 8042501450180425014501 | 30 CAPSULE in 1 BOTTLE (80425-0145-1)Marketed from Aug 26, 2009 | |
| 80425-0145-2 | 8042501450280425014502 | 21 CAPSULE in 1 BOTTLE (80425-0145-2)Marketed from Mar 30, 2023 | |
| 80425-0145-3 | 8042501450380425014503 | 28 CAPSULE in 1 BOTTLE (80425-0145-3)Marketed from Sep 12, 2023 |
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 HCL
- Generic name (nonproprietary)
- clindamycin hcl
- Active ingredients
- Clindamycin hydrochloride — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0145_2a999573-1034-813a-e063-6294a90a49b1SPL ID 2a999573-1034-813a-e063-6294a90a49b1SPL set ID c46cac0a-0c36-02fa-e053-2995a90a772bRxCUI 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
N480425014501followed by a unit qualifier and the quantityPackage 80425-0145-01. 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 Section INDICATIONS AND USAGE Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules 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 altern…
Excerpt only. Read the full label for complete information.
About NDC 80425-0145
- What is NDC 80425-0145?
- 80425-0145 is the product NDC for Clindamycin HCL, Clindamycin hydrochloride 300 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin HCL.
- What is the active ingredient?
- Clindamycin hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 HCL?
- 1 other product NDC are listed under this name. See all Clindamycin HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin HCL 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 HCL | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0103 | 80425-0103-01 |
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 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 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-185 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | Redpharm Drug | 67296-0940 |
| Clindamycin Hydrochloride | Clindamycin hydrochloride 300 mg/1 | CapsuleOral | VERITYRX, LLC | 83939-0019 |