Prescription drug · ANDA
minocycline hydrochloride NDC 70771-1158
Minocycline hydrochloride 115 mg/1 · Tablet, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1158-0 | 70771115800 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-0)Marketed from Jun 12, 2025 | |
| 70771-1158-1 | 70771115801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-1)Marketed from Jun 12, 2025 | |
| 70771-1158-3 | 70771115803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-3)Marketed from Jun 12, 2025 | |
| 70771-1158-5 | 70771115805 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-5)Marketed from Jun 12, 2025 | |
| 70771-1158-7 | 70771115807 | 10 BLISTER PACK in 1 CARTON (70771-1158-7) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 12, 2025 | |
| 70771-1158-9 | 70771115809 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-9)Marketed from Jun 12, 2025 |
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)
- minocycline hydrochloride
- Generic name (nonproprietary)
- minocycline hydrochloride
- Active ingredients
- Minocycline hydrochloride — 115 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203553
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 70771-1158_5f19958c-a2d2-4ef1-accd-17186e623625SPL ID 5f19958c-a2d2-4ef1-accd-17186e623625SPL set ID 8bf9cf23-8ffc-401f-981d-4878d694a468RxCUI 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665UNII 0020414E5UUPC 0370771115419, 0370771115310, 0370771115617, 0370771115518, 0370771116713, 0370771115815, 0370771115716, 0370771113811
- 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.
- NDC on a medical claim
N470771115800followed by a unit qualifier and the quantityPackage 70771-1158-00. 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 .
Indications (excerpt from the label)
Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14) ] . To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12) ] . Minocycline hydrochloride ex…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203553
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 65 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-532 |
| minocycline hydrochloride | Minocycline hydrochloride 45 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-531 |
| minocycline hydrochloride | Minocycline hydrochloride 90 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-533 |
| minocycline hydrochloride | Minocycline hydrochloride 115 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-534 |
| minocycline hydrochloride | Minocycline hydrochloride 135 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-535 |
| minocycline hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-550 |
| minocycline hydrochloride | Minocycline hydrochloride 80 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-551 |
| minocycline hydrochloride | Minocycline hydrochloride 105 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-552 |
| minocycline hydrochloride | Minocycline hydrochloride 45 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1138 |
| minocycline hydrochloride | Minocycline hydrochloride 65 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1154 |
| minocycline hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1153 |
| minocycline hydrochloride | Minocycline hydrochloride 90 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1156 |
| minocycline hydrochloride | Minocycline hydrochloride 80 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1155 |
| minocycline hydrochloride | Minocycline hydrochloride 105 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1157 |
| minocycline hydrochloride | Minocycline hydrochloride 135 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1167 |