Prescription drug · ANDA
Minocycline Hydrochloride NDC 72789-524
Minocycline hydrochloride 65 mg/1 · Tablet, Film coated, Extended release · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-524-30 | 72789052430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-524-30)Marketed from Sep 10, 2025 |
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 — 65 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204453
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 72789-524_57ee7122-b58f-b7e9-e063-6394a90a6d72SPL ID 57ee7122-b58f-b7e9-e063-6394a90a6d72SPL set ID 3e796794-b731-61d6-e063-6394a90aa9b3RxCUI 629695, 629697, 858062, 858372, 1013659, 1013662, 1013665UNII 0020414E5U
- 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
N472789052430followed by a unit qualifier and the quantityPackage 72789-0524-30. 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 is 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 ext…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204453
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 45 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-523 |
| Minocycline Hydrochloride | Minocycline hydrochloride 80 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-527 |
| Minocycline Hydrochloride | Minocycline hydrochloride 90 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-525 |
| Minocycline Hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-526 |
| Minocycline Hydrochloride | Minocycline hydrochloride 105 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-528 |
| Minocycline Hydrochloride | Minocycline hydrochloride 115 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-529 |
| Minocycline Hydrochloride | Minocycline hydrochloride 135 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-530 |
| Minocycline Hydrochloride | Minocycline hydrochloride 105 mg/1 | Tablet, Film coated, Extended releaseOral | Ascend Laboratories, LLC | 67877-438 |
| Minocycline Hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Film coated, Extended releaseOral | Ascend Laboratories, LLC | 67877-436 |
| Minocycline Hydrochloride | Minocycline hydrochloride 80 mg/1 | Tablet, Film coated, Extended releaseOral | Ascend Laboratories, LLC | 67877-437 |
| Minocycline Hydrochloride | Minocycline hydrochloride 105 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2904 |
| Minocycline Hydrochloride | Minocycline hydrochloride 105 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1840 |
| Minocycline Hydrochloride | Minocycline hydrochloride 55 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1838 |
| Minocycline Hydrochloride | Minocycline hydrochloride 80 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1839 |
| Minocycline Hydrochloride | Minocycline hydrochloride 135 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1853 |
| Minocycline Hydrochloride | Minocycline hydrochloride 90 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1852 |
| Minocycline Hydrochloride | Minocycline hydrochloride 45 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1854 |
| Minocycline Hydrochloride | Minocycline hydrochloride 115 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1868 |
| Minocycline Hydrochloride | Minocycline hydrochloride 65 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1867 |
| Minocycline Hydrochloride | Minocycline hydrochloride 45 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2711 |
Showing 20 of 35.