Prescription drug · ANDA
Minocycline Hydrochloride NDC 59651-337
Minocycline hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-337-01 | 59651033701 | 100 TABLET, FILM COATED in 1 CONTAINER (59651-337-01)Marketed from May 1, 2020 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213662
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 59651-337_2ef3b8ae-dd97-473f-bd81-c8c1b192c0edSPL ID 2ef3b8ae-dd97-473f-bd81-c8c1b192c0edSPL set ID 799a9871-3249-471e-b88d-5d8f7d4b96adRxCUI 207362, 207364, 403840UNII 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
N459651033701followed by a unit qualifier and the quantityPackage 59651-0337-01. 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 tablets 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 Chlamydia 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 urethritis, endo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213662
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 75 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-338 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-339 |