Prescription drug · ANDA
Doxycycline Hyclate NDC 46708-482
Doxycycline hyclate 100 mg/1 · Tablet, Delayed release · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-482-31 | 46708048231 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-31)Marketed from Jan 4, 2022 | |
| 46708-482-60 | 46708048260 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-60)Marketed from Jan 4, 2022 | |
| 46708-482-91 | 46708048291 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-91)Marketed from Jan 4, 2022 |
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, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213075
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 46708-482_e1387662-e286-469d-b85f-60344918a17bSPL ID e1387662-e286-469d-b85f-60344918a17bSPL set ID 44ac5de1-c0c6-4d58-9a49-b2dae60ea921RxCUI 406524, 434018, 799048, 1423080UNII 19XTS3T51UUPC 0346708483609, 0346708482602, 0346708481605, 0346708484606
- 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
N446708048231followed by a unit qualifier and the quantityPackage 46708-0482-31. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets 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. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or disease. Doxyc…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213075
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 200 mg/1 | Tablet, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-484 |
| Doxycycline Hyclate | Doxycycline hyclate 75 mg/1 | Tablet, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-481 |
| Doxycycline Hyclate | Doxycycline hyclate 150 mg/1 | Tablet, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-483 |
| Doxycycline Hyclate | Doxycycline hyclate 75 mg/1 | Tablet, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-481 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-482 |
| Doxycycline Hyclate | Doxycycline hyclate 150 mg/1 | Tablet, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-483 |
| Doxycycline Hyclate | Doxycycline hyclate 200 mg/1 | Tablet, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-484 |