Prescription drug · ANDA
Doxycycline Hyclate NDC 62332-388
Doxycycline hyclate 150 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-388-60 | 62332038860 | 60 TABLET, FILM COATED in 1 BOTTLE (62332-388-60)Marketed from Jun 30, 2020 | |
| 62332-388-91 | 62332038891 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-388-91)Marketed from Jun 30, 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)
- Doxycycline Hyclate
- Generic name (nonproprietary)
- doxycycline hyclate
- Active ingredients
- Doxycycline hyclate — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211744
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 62332-388_23a5f41d-9033-4744-9ac4-e2e3fe39e6b5SPL ID 23a5f41d-9033-4744-9ac4-e2e3fe39e6b5SPL set ID cec4368f-2852-443d-9d6f-7ba95807021bRxCUI 1649425, 1650446UNII 19XTS3T51UUPC 0362332388608, 0362332387601
- 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
N462332038860followed by a unit qualifier and the quantityPackage 62332-0388-60. 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)
Doxycycline hyclate tablets are tetracycline class drugs indicated for: · Rickettsial infections ( 1.1 ) · Sexually transmitted infections ( 1.2 ) · Respiratory tract infections ( 1.3 ) · Specific bacterial infections ( 1.4 ) · Ophthalmic infections ( 1.5 ) · Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) · Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) · Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8 ) · Prophylaxis of malaria ( 1.9 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets sh…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211744
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 |
|---|---|---|---|---|
| Doxycycline Hyclate | Doxycycline hyclate 75 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-387 |
| Doxycycline Hyclate | Doxycycline hyclate 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-388 |
| Doxycycline Hyclate | Doxycycline hyclate 75 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-387 |