Prescription drug · ANDA
Minocycline Hydrochloride NDC 13668-484
Minocycline hydrochloride 100 mg/1 · Capsule · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-484-05 | 13668048405 | 500 CAPSULE in 1 BOTTLE (13668-484-05)Marketed from Apr 2, 2015 | |
| 13668-484-50 | 13668048450 | 50 CAPSULE in 1 BOTTLE (13668-484-50)Marketed from Apr 2, 2015 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065062
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 13668-484_4ee4f6d7-55da-406d-9a32-de923b01c15cSPL ID 4ee4f6d7-55da-406d-9a32-de923b01c15cSPL set ID 55df55fb-18ec-4e00-9ed0-10bba0da513bRxCUI 197984, 197985, 314108UNII 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
N413668048405followed by a unit qualifier and the quantityPackage 13668-0484-05. 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 urethr…
Excerpt only. Read the full label for complete information.
About NDC 13668-484
- What is NDC 13668-484?
- 13668-484 is the product NDC for Minocycline Hydrochloride, Minocycline hydrochloride 100 mg/1 capsule, listed with the FDA by Torrent Pharmaceuticals Limited. It has 2 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?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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?
- 116 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 065062
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 100 mg/1 | CapsuleOral | Major Pharamceuticals | 0904-6888 |
| Minocycline Hydrochloride | Minocycline hydrochloride 50 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-482 |
| Minocycline Hydrochloride | Minocycline hydrochloride 75 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-483 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-736 |
| Minocycline Hydrochloride | Minocycline hydrochloride 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2971 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | American Health Packaging | 60687-336 |
| Minocycline hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-036 |
| Minocycline hydrochloride | Minocycline hydrochloride 50 mg/1 | CapsuleOral | Proficient Rx LP | 63187-450 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-850 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2866 |
| Minocycline Hydrochloride | Minocycline hydrochloride 50 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3635 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0046 |
| Minocycline Hydrochloride | Minocycline hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2573 |
| Minocycline Hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2574 |
| Minocycline hydrochloride | Minocycline hydrochloride 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0314 |