Prescription drug · ANDA
Doxycycline Hyclate NDC 62135-625
Doxycycline hyclate 50 mg/1 · Tablet, Film coated · Oral · Chartwell RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-625-60 | 62135062560 | 60 TABLET, FILM COATED in 1 BOTTLE (62135-625-60)Marketed from Jul 27, 2021 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Chartwell RX LLC
- 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 62135-625_40077986-5ebb-f8f0-e063-6394a90ad09fSPL ID 40077986-5ebb-f8f0-e063-6394a90ad09fSPL set ID 3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35RxCUI 1649405, 1649988, 1650030, 1650143, 1652674UNII 19XTS3T51U, N12000U13OUPC 0362135626129, 0362135626280, 0362135417468, 0362135985059, 0362135985103, 0362135626013, 0362135984052, 0362135626310, 0362135626105, 0362135626969, 0362135877460, 0362135625603, 0362135985011
- 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
N462135062560followed by a unit qualifier and the quantityPackage 62135-0625-60. 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 | NuCare Pharmaceuticals,Inc. | 68071-5265 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | Chartwell RX LLC | 62135-626 |
| 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 |