Prescription drug · ANDA
Doxycycline NDC 70518-0213
Doxycycline 100 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0213-0 | 70518021300 | 30 CAPSULE in 1 BLISTER PACK (70518-0213-0)Marketed from Feb 10, 2017 | |
| 70518-0213-1 | 70518021301 | 20 CAPSULE in 1 BLISTER PACK (70518-0213-1)Marketed from Feb 10, 2017 | |
| 70518-0213-2 | 70518021302 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-0213-2)Marketed from May 31, 2017 | |
| 70518-0213-3 | 70518021303 | 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-0213-3)Marketed from Jul 17, 2017 | |
| 70518-0213-7 | 70518021307 | 14 CAPSULE in 1 BLISTER PACK (70518-0213-7)Marketed from Mar 17, 2020 |
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 — 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 204234
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 70518-0213_55015b68-494f-f50c-e063-6394a90a6137SPL ID 55015b68-494f-f50c-e063-6394a90a6137SPL set ID fa2d9328-b688-47af-8c4d-dc328cf35392RxCUI 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
N470518021300followed by a unit qualifier and the quantityPackage 70518-0213-00. 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 capsules and other antibacterial drugs, doxycycline capsules 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 is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus gro…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204234
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 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-672 |
| Doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-650 |
| Doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-652 |
| Doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-711 |