Prescription drug · ANDA
Doxycycline Hyclate NDC 68071-3466
Doxycycline hyclate 100 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3466-1 | 68071346601 | 10 TABLET in 1 BOTTLE (68071-3466-1)Marketed from Jul 21, 2023 | |
| 68071-3466-2 | 68071346602 | 20 TABLET in 1 BOTTLE (68071-3466-2)Marketed from Aug 21, 2026 | |
| 68071-3466-7 | 68071346607 | 14 TABLET in 1 BOTTLE (68071-3466-7)Marketed from Jul 21, 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 Hyclate
- Generic name (nonproprietary)
- doxycycline hyclate
- Active ingredients
- Doxycycline hyclate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211343
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 68071-3466_59f9ebe9-3801-6038-e063-6294a90a1fa5SPL ID 59f9ebe9-3801-6038-e063-6294a90a1fa5SPL set ID 0106a3d3-db4d-f6ee-e063-6294a90a25e9RxCUI 1650143UNII 19XTS3T51UUPC 0368071346671
- 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
N468071346601followed by a unit qualifier and the quantityPackage 68071-3466-01. 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)
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 f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211343
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 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-723 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Redpharm Drug | 67296-2075 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2639 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3869 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4544 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-234 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9718 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Direct_Rx | 72189-603 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Proficient Rx LP | 82804-070 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2402 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Redpharm Drug | 67296-2075 |