Prescription drug · ANDA
Minocycline Hydrochloride NDC 65862-884
Minocycline hydrochloride 80 mg/1 · Tablet, Film coated, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-884-01 | 65862088401 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-01)Marketed from Jun 13, 2016 | |
| 65862-884-05 | 65862088405 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-05)Marketed from Jun 13, 2016 | |
| 65862-884-30 | 65862088430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-30)Marketed from Jun 13, 2016 | |
| 65862-884-99 | 65862088499 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-99)Marketed from Jun 13, 2016 |
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)
- Minocycline Hydrochloride
- Generic name (nonproprietary)
- minocycline hydrochloride
- Active ingredients
- Minocycline hydrochloride — 80 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202261
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 65862-884_5569f0f6-b36f-4149-aee7-2699fa5ebe53SPL ID 5569f0f6-b36f-4149-aee7-2699fa5ebe53SPL set ID e7b88a48-12b3-461d-b356-0d7ae4e8fd44RxCUI 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665UNII 0020414E5UUPC 0365862555304
- 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
N465862088401followed by a unit qualifier and the quantityPackage 65862-0884-01. 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 .
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 is …
Excerpt only. Read the full label for complete information.
About NDC 65862-884
- What is NDC 65862-884?
- 65862-884 is the product NDC for Minocycline Hydrochloride, Minocycline hydrochloride 80 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Minocycline Hydrochloride.
- What is the active ingredient?
- Minocycline 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 Minocycline Hydrochloride?
- 124 other product NDCs are listed under this name. See all Minocycline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Minocycline 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) |
|---|---|---|---|---|---|
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4565 | 70518-4565-00 |
| minocycline hydrochloride | Minocycline hydrochloride 65 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-532 | 68382-0532-0168382-0532-0568382-0532-06+3 more |
| minocycline hydrochloride | Minocycline hydrochloride 115 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-534 | 68382-0534-0168382-0534-0568382-0534-06+3 more |
| minocycline hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-550 | 68382-0550-0168382-0550-0568382-0550-06+3 more |
| minocycline hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1153 | 70771-1153-0070771-1153-0170771-1153-03+3 more |
| minocycline hydrochloride | Minocycline hydrochloride 65 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1154 | 70771-1154-0070771-1154-0170771-1154-03+3 more |
| minocycline hydrochloride | Minocycline hydrochloride 115 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1158 | 70771-1158-0070771-1158-0170771-1158-03+3 more |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0390 | 80425-0390-0180425-0390-0280425-0390-03 |
| Minocycline hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-017 | 82868-0017-60 |
| Minocycline hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0314 | 80425-0314-0180425-0314-0280425-0314-03 |
Other NDCs under ANDA 202261
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 105 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-885 |
| Minocycline Hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-883 |
| Minocycline Hydrochloride | Minocycline hydrochloride 45 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-554 |
| Minocycline Hydrochloride | Minocycline hydrochloride 135 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-558 |
| Minocycline Hydrochloride | Minocycline hydrochloride 65 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-555 |
| Minocycline Hydrochloride | Minocycline hydrochloride 90 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-556 |
| Minocycline Hydrochloride | Minocycline hydrochloride 115 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-557 |