Prescription drug · ANDA
Doxycycline Hyclate NDC 0143-2112
Doxycycline hyclate 100 mg/1 · Tablet, Coated · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-2112-05 | 00143211205 | 500 TABLET, COATED in 1 BOTTLE (0143-2112-05)Marketed from Jul 2, 2003 | |
| 0143-2112-50 | 00143211250 | 50 TABLET, COATED in 1 BOTTLE (0143-2112-50)Marketed from Jul 2, 2003 |
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 — 100 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065095
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 0143-2112_d3f0f038-6c53-4f67-8397-c6d0ef71a60bSPL ID d3f0f038-6c53-4f67-8397-c6d0ef71a60bSPL set ID 9b52e0a7-f024-4d8a-a59e-374946e60b44RxCUI 1650143UNII 19XTS3T51UUPC 0301432112508
- 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
N400143211205followed by a unit qualifier and the quantityPackage 00143-2112-05. 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 Tablets and other antibacterial drugs, Doxycycline Hyclate 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. Treatment Doxycycline is indicated for the treatment of the following infections: • Rocky Mountain spotted fever, typhu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065095
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 100 mg/1 | Tablet, CoatedOral | QPharma, Inc. | 42708-173 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Cardinal Health 107, LLC | 55154-8079 |
| Doxycyclinedoxycycline hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-3039 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 51655-998 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Major Pharmaceuticals | 0904-0430 |
| Doxycyclinedoxycycline hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-866 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | American Health Packaging | 62584-693 |
| Doxycyclinedoxycycline hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Cardinal Health 107, LLC | 55154-7128 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7580 |