Prescription drug · ANDA
Minocycline Hydrochloride NDC 80425-0390
Minocycline hydrochloride 100 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0390-1 | 80425039001 | 30 CAPSULE in 1 BOTTLE (80425-0390-1)Marketed from May 23, 2024 | |
| 80425-0390-2 | 80425039002 | 60 CAPSULE in 1 BOTTLE (80425-0390-2)Marketed from May 23, 2024 | |
| 80425-0390-3 | 80425039003 | 90 CAPSULE in 1 BOTTLE (80425-0390-3)Marketed from May 23, 2024 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065470
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 80425-0390_19233bc0-9973-2002-e063-6394a90a057cSPL ID 19233bc0-9973-2002-e063-6394a90a057cSPL set ID 192327c5-d2bc-1bd1-e063-6394a90a110bRxCUI 197984UNII 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
N480425039001followed by a unit qualifier and the quantityPackage 80425-0390-01. 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)
INDICATIONS AND USAGE Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae . Respiratory tract infections caused by Mycoplasma pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis . Psittacosis (Ornithosis) due to Chlamydophila psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis . Nongonococcal ureth…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065470
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 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3016 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-004 |
| Minocycline Hydrochloride | Minocycline hydrochloride 50 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-209 |
| Minocycline Hydrochloride | Minocycline hydrochloride 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-210 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7052 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-211 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2225 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1123 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1336 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2579 |
| Minocycline Hydrochloride | Minocycline hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1237 |
| Minocycline Hydrochloride | Minocycline hydrochloride 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2564 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-272 |