Prescription drug · ANDA
Doxycycline Hyclate NDC 0591-4575
Doxycycline hyclate 200 mg/1 · Tablet, Delayed release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-4575-60 | 00591457560 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-4575-60)Marketed from Aug 14, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090134
- Marketing start
- Marketing end
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 0591-4575_304ae0bb-5f05-4389-8952-5a99391b8047SPL ID 304ae0bb-5f05-4389-8952-5a99391b8047SPL set ID c2b08332-3256-4658-965a-ede3d973a388RxCUI 1423080, 1653433UNII 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
N400591457560followed by a unit qualifier and the quantityPackage 00591-4575-60. 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 delayed-release tablets are a tetracycline-class drug 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 in acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycyclin…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090134
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, Delayed releaseOral | Actavis Pharma, Inc. | 0591-4550 |