Prescription drug · ANDA
Doxycycline Hyclate NDC 61919-082
Doxycycline hyclate 100 mg/1 · Capsule · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-082-20 | 61919008220 | 20 CAPSULE in 1 BOTTLE (61919-082-20)Marketed from Jan 1, 2015 | |
| 61919-082-30 | 61919008230 | 30 CAPSULE in 1 BOTTLE (61919-082-30)Marketed from Jan 1, 2014 | |
| 61919-082-60 | 61919008260 | 60 CAPSULE in 1 BOTTLE (61919-082-60)Marketed from Jan 1, 2015 |
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
- Capsule
- Route
- Oral
- Labeler
- DIRECT RX
- 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 61919-082_4c47f8bd-4a1e-dd8f-e063-6294a90a29d8SPL ID 4c47f8bd-4a1e-dd8f-e063-6294a90a29d8SPL set ID 9798c4de-8af7-41c4-acc2-1e9775194297RxCUI 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
N461919008220followed by a unit qualifier and the quantityPackage 61919-0082-20. 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 & USAGE SECTION 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…
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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0211 |
| 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 | 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 |