Prescription drug · ANDA
Minocycline Hydrochloride NDC 68180-381
Minocycline hydrochloride 135 mg/1 · Tablet, Extended release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Minocycline Hydrochloride
- Generic name (nonproprietary)
- minocycline hydrochloride
- Active ingredients
- Minocycline hydrochloride — 135 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091424
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 68180-381_ad320f99-9382-4ef0-b6b6-86542020555aSPL ID ad320f99-9382-4ef0-b6b6-86542020555aSPL set ID 3b1e1cf1-ebd2-4aba-a219-9f9939fdb03bRxCUI 629695, 629697, 629699, 1013662UNII 0020414E5UUPC 0368180460060
- Pharmacologic class
- Tetracycline-class Drug
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Minocycline hydrochloride extended-release tablets USP are tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) 1.1 Indication Minocycline hydrochloride extended-release tablets USP are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.2 Limitations of Use Minocycline hydrochloride extended-release tablets USP did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets USP have not been established beyond 12 weeks of use. This formulatio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091424
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 |
|---|---|---|---|---|
| Minocycline Hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-460 |
| Minocycline Hydrochloride | Minocycline hydrochloride 45 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-379 |
| Minocycline Hydrochloride | Minocycline hydrochloride 90 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-380 |