Prescription drug · ANDA
Doxycycline Hyclate NDC 62332-353
Doxycycline hyclate 100 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-353-20 | 62332035320 | 20 TABLET, FILM COATED in 1 BOTTLE (62332-353-20)Marketed from May 15, 2020 | |
| 62332-353-50 | 62332035350 | 50 TABLET, FILM COATED in 1 BOTTLE (62332-353-50)Marketed from May 15, 2020 | |
| 62332-353-71 | 62332035371 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-353-71)Marketed from May 15, 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 — 100 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 210536
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 62332-353_df132f03-b61e-4786-bdc4-cb7b26c7b003SPL ID df132f03-b61e-4786-bdc4-cb7b26c7b003
- 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
N462332035320followed by a unit qualifier and the quantityPackage 62332-0353-20. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 210536
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 50 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-499 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-499 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-353 |