Prescription drug · ANDA
doxycycline NDC 70518-3488
Doxycycline hyclate 100 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3488-0 | 70518348800 | 20 CAPSULE in 1 BLISTER PACK (70518-3488-0)Marketed from Aug 22, 2022 | |
| 70518-3488-1 | 70518348801 | 30 CAPSULE in 1 BLISTER PACK (70518-3488-1)Marketed from Sep 7, 2022 | |
| 70518-3488-2 | 70518348802 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-2)Marketed from Dec 14, 2022 | |
| 70518-3488-3 | 70518348803 | 28 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-3)Marketed from Aug 2, 2023 | |
| 70518-3488-4 | 70518348804 | 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-4)Marketed from Oct 24, 2023 | |
| 70518-3488-6 | 70518348806 | 56 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-6)Marketed from Feb 27, 2025 | |
| 70518-3488-7 | 70518348807 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-7)Marketed from Aug 22, 2025 | |
| 70518-3488-8 | 70518348808 | 50 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-8)Marketed from Nov 17, 2025 | |
| 70518-3488-9 | 70518348809 | 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-9)Marketed from May 5, 2026 |
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
- Generic name (nonproprietary)
- doxycycline
- Active ingredients
- Doxycycline hyclate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209402
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 70518-3488_58b75f14-35b1-fd4c-e063-6394a90aefc7SPL ID 58b75f14-35b1-fd4c-e063-6394a90aefc7SPL set ID f0fbf63a-e75c-40cf-b2e9-429deaac899dRxCUI 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
N470518348800followed by a unit qualifier and the quantityPackage 70518-3488-00. 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 f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209402
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 hyclate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4655 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4176 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-721 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2100 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7410 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7411 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8588 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-046 |
| Doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Health Department, Oklahoma State | 83112-233 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Diirect_rx | 72189-559 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-562 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Cranbury Pharmaceuticals, LLC | 27808-233 |