Prescription drug · ANDA
Doxycycline Hyclate NDC 80425-0211
Doxycycline hyclate 100 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0211-1 | 80425021101 | 20 CAPSULE in 1 BOTTLE (80425-0211-1)Marketed from Nov 4, 2023 | |
| 80425-0211-2 | 80425021102 | 10 CAPSULE in 1 BOTTLE (80425-0211-2)Marketed from Nov 4, 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
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062676
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 80425-0211_2a99c981-daf7-71e5-e063-6294a90a5c1dSPL ID 2a99c981-daf7-71e5-e063-6294a90a5c1dSPL set ID ecab47ea-d7b9-515d-e053-2995a90adc46RxCUI 1649988UNII 19XTS3T51U
- 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
N480425021101followed by a unit qualifier and the quantityPackage 80425-0211-01. 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 062676
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 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-277 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-298 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 53489-119 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 53489-118 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Proficient Rx LP | 71205-653 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | DIRECT RX | 61919-082 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Quality Care Products, LLC | 49999-126 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-369 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0280 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1248 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | AvPAK | 50268-277 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | AvPAK | 50268-278 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3564 |