Prescription drug · ANDA
Doxycycline Hyclate NDC 68071-5265
Doxycycline hyclate 100 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5265-2 | 68071526502 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-5265-2)Marketed from Jun 1, 2020 | |
| 68071-5265-7 | 68071526507 | 14 TABLET, FILM COATED in 1 BOTTLE (68071-5265-7)Marketed from Jun 1, 2020 |
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 Hyclate
- Generic name (nonproprietary)
- doxycycline hyclate
- Active ingredients
- Doxycycline hyclate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062505
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 68071-5265_1d78d7d4-4389-eab7-e063-6394a90a9e7fSPL ID 1d78d7d4-4389-eab7-e063-6394a90a9e7fSPL set ID a707c9e3-00eb-e832-e053-2a95a90a5f58RxCUI 1650143UNII 19XTS3T51UUPC 0368071526523
- 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
N468071526502followed by a unit qualifier and the quantityPackage 68071-5265-02. 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 and other antibacterial drugs, doxycycline 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, typhus fever and the typhus group, Q fev…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062505
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, Film coatedOral | direct rx | 72189-127 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-697 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-298 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Chartwell RX LLC | 62135-626 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | Tablet, Film coatedOral | Chartwell RX LLC | 62135-625 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4981 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Redpharm Drug, Inc. | 67296-1456 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1686 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | Tablet, Film coatedOral | Chartwell Governmental & Specialty RX, LLC | 68999-625 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Chartwell Governmental & Specialty RX, LLC | 68999-626 |