Prescription drug · ANDA
Doxycycline Hyclate NDC 24658-310
Doxycycline hyclate 100 mg/1 · Tablet, Film coated · Oral · PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24658-310-01 | 24658031001 | 100 TABLET, FILM COATED in 1 BOTTLE (24658-310-01)Marketed from Mar 7, 2025 | |
| 24658-310-05 | 24658031005 | 500 TABLET, FILM COATED in 1 BOTTLE (24658-310-05)Marketed from Mar 7, 2025 | |
| 24658-310-07 | 24658031007 | 300 TABLET, FILM COATED in 1 BOTTLE (24658-310-07)Marketed from Apr 14, 2025 | |
| 24658-310-08 | 24658031008 | 400 TABLET, FILM COATED in 1 BOTTLE (24658-310-08)Marketed from Apr 14, 2025 | |
| 24658-310-10 | 24658031010 | 1000 TABLET, FILM COATED in 1 BOTTLE (24658-310-10)Marketed from Mar 7, 2025 | |
| 24658-310-20 | 24658031020 | 20 TABLET, FILM COATED in 1 BOTTLE (24658-310-20)Marketed from Mar 7, 2025 | |
| 24658-310-21 | 24658031021 | 210 TABLET, FILM COATED in 1 BOTTLE (24658-310-21)Marketed from Apr 14, 2025 | |
| 24658-310-30 | 24658031030 | 30 TABLET, FILM COATED in 1 BOTTLE (24658-310-30)Marketed from Apr 14, 2025 | |
| 24658-310-50 | 24658031050 | 50 TABLET, FILM COATED in 1 BOTTLE (24658-310-50)Marketed from Mar 7, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062269
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 24658-310_65cac0b6-3550-48cf-bffa-cf42443c2731SPL ID 65cac0b6-3550-48cf-bffa-cf42443c2731SPL set ID 65cac0b6-3550-48cf-bffa-cf42443c2731RxCUI 1650143UNII 19XTS3T51UUPC 0324658310503, 0324658310213
- 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
N424658031001followed by a unit qualifier and the quantityPackage 24658-0310-01. 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 hyclate and other antibacterial drugs, doxycycline hyclate 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062269
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 | REMEDYREPACK INC. | 70518-4510 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3214 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2189 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | Tablet, Film coatedOral | JG Pharma Inc. | 72143-262 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4836 |
| Targadoxdoxycycline hyclate | Doxycycline hyclate 50 mg/1 | TabletOral | Journey Medical Corporation | 69489-111 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Health Department, Oklahoma State | 83112-100 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7800 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7546 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7547 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-310 |