Prescription drug · ANDA
Doxycycline Monohydrate NDC 80425-0319
Doxycycline 100 mg/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0319-1 | 80425031901 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0319-1)Marketed from Apr 11, 2023 | |
| 80425-0319-2 | 80425031902 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0319-2)Marketed from Apr 11, 2023 | |
| 80425-0319-3 | 80425031903 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0319-3)Marketed from Apr 11, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Monohydrate
- Generic name (nonproprietary)
- doxycycline monohydrate
- Active ingredients
- Doxycycline — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209582
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 80425-0319_2a9bf7d3-46da-0dfa-e063-6394a90a76a4SPL ID 2a9bf7d3-46da-0dfa-e063-6394a90a76a4SPL set ID f91373f2-c57b-f1f1-e053-6294a90a7bddRxCUI 1650142UNII N12000U13O
- 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
N480425031901followed by a unit qualifier and the quantityPackage 80425-0319-01. 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 tablets and other antibacterial drugs, doxycycline 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 indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickett…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209582
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 | Doxycycline 50 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1121 |
| Doxycycline | Doxycycline 150 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1124 |
| Doxycycline | Doxycycline 75 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1122 |
| Doxycycline | Doxycycline 100 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1123 |
| Doxycycline | Doxycycline 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2638 |
| Doxycycline | Doxycycline 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-028 |
| Doxycycline | Doxycycline 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3809 |
| Doxycycline | Doxycycline 75 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1007 |
| Doxycycline | Doxycycline 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1006 |
| Doxycycline | Doxycycline 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1008 |
| Doxycycline | Doxycycline 150 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1009 |