Prescription drug · ANDA
Doxycycline Hyclate NDC 62332-352
Doxycycline hyclate 20 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-352-31 | 62332035231 | 100 TABLET, FILM COATED in 1 BOTTLE (62332-352-31)Marketed from Mar 5, 2020 | |
| 62332-352-60 | 62332035260 | 60 TABLET, FILM COATED in 1 BOTTLE (62332-352-60)Marketed from Mar 5, 2020 | |
| 62332-352-91 | 62332035291 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-352-91)Marketed from Mar 5, 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 — 20 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 210537
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 62332-352_9d36c4e4-75df-42af-bd04-37ccfe7664a7SPL ID 9d36c4e4-75df-42af-bd04-37ccfe7664a7SPL set ID 7c33c1b8-100e-4df8-be8d-de3eed7ced94RxCUI 283535UNII 19XTS3T51U
- 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
N462332035231followed by a unit qualifier and the quantityPackage 62332-0352-31. 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 Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210537
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 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-352 |