Prescription drug · ANDA
Doxycycline Monohydrate NDC 61919-624
Doxycycline 100 mg/1 · Capsule · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-624-14 | 61919062414 | 14 CAPSULE in 1 BOTTLE (61919-624-14)Marketed from Apr 5, 2019 | |
| 61919-624-20 | 61919062420 | 20 CAPSULE in 1 BOTTLE (61919-624-20)Marketed from Apr 5, 2019 | |
| 61919-624-30 | 61919062430 | 30 CAPSULE in 1 BOTTLE (61919-624-30)Marketed from Apr 5, 2019 |
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 Monohydrate
- Generic name (nonproprietary)
- doxycycline monohydrate
- Active ingredients
- Doxycycline — 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 205115
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 61919-624_4c4a0016-0fb6-1dc9-e063-6294a90a9541SPL ID 4c4a0016-0fb6-1dc9-e063-6294a90a9541SPL set ID 31512ece-cb16-2a9a-e054-00144ff88e88RxCUI 1649990UNII N12000U13O
- 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
N461919062414followed by a unit qualifier and the quantityPackage 61919-0624-14. 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 capsules, USP and other antibacterial drugs, doxycycline capsules, USP 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. Doxycycline capsules, USP are indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205115
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 | Doxycycline 50 mg/1 | CapsuleOral | AvPAK | 50268-280 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | AvPAK | 50268-281 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1260 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-491 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-496 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-158 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-159 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-712 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-823 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-821 |
| doxycycline | Doxycycline 75 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-822 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1479 |
| doxycycline | Doxycycline 75 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-706 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-707 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4833 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-782 |