Prescription drug · ANDA
doxycycline hyclate NDC 62332-362
Doxycycline hyclate 50 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-362-50 | 62332036250 | 50 CAPSULE in 1 BOTTLE (62332-362-50)Marketed from Jun 18, 2018 | |
| 62332-362-71 | 62332036271 | 500 CAPSULE in 1 BOTTLE (62332-362-71)Marketed from Jun 18, 2018 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210527
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 62332-362_2a82cd02-f9ad-41c6-8c57-21ae980b3a39SPL ID 2a82cd02-f9ad-41c6-8c57-21ae980b3a39SPL set ID 131af052-0c4f-4a61-ae9a-e6165ae09076RxCUI 1649405, 1649988UNII 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
N462332036250followed by a unit qualifier and the quantityPackage 62332-0362-50. 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 To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules, USP and other antibacterial drugs, doxycycline hyclate capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210527
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 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-362 |
| doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-363 |
| doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-363 |