Prescription drug · ANDA
Doxycycline NDC 63304-615
Doxycycline 75 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-615-01 | 63304061501 | 100 CAPSULE in 1 BOTTLE (63304-615-01)Marketed from Dec 26, 2000 | |
| 63304-615-05 | 63304061505 | 500 CAPSULE in 1 BOTTLE (63304-615-05)Marketed from Dec 26, 2000 | |
| 63304-615-11 | 63304061511 | 1 BLISTER PACK in 1 CARTON (63304-615-11) / 1 CAPSULE in 1 BLISTER PACKMarketed from Dec 26, 2000 |
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
- Generic name (nonproprietary)
- doxycycline
- Active ingredients
- Doxycycline — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065053
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 63304-615_338488d1-e9d8-6b00-e063-6294a90a37c0SPL ID 338488d1-e9d8-6b00-e063-6294a90a37c0SPL set ID 829dbd3d-5c2b-47b8-96a5-423af78c93b9RxCUI 700408, 1649401, 1649990UNII N12000U13OUPC 0363304614015
- 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
N463304061501followed by a unit qualifier and the quantityPackage 63304-0615-01. 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 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.
About NDC 63304-615
- What is NDC 63304-615?
- 63304-615 is the product NDC for Doxycycline, Doxycycline 75 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxycycline.
- What is the active ingredient?
- Doxycycline.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxycycline?
- 135 other product NDCs are listed under this name. See all Doxycycline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxycycline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxycycline | Doxycycline 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4762 | 70518-4762-00 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-158 | 48433-0158-03 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-159 | 48433-0159-03 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1260 | 67046-1260-03 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4176 | 68788-4176-0068788-4176-0168788-4176-02+3 more |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4655 | 70518-4655-0070518-4655-01 |
| Doxycycline | Doxycycline hyclate 100 mg/100mg | Injection, Powder, Lyophilized, For solutionIntravenous | Steriscience Specialties Private Limited | 82449-008 | 82449-0008-02 |
| Doxycycline | Doxycycline 100 mg/1 | CapsuleOral | American Health Packaging | 60687-943 | 60687-0943-21 |
| Doxycycline | Doxycycline hyclate 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | JVET PHARMACEUTICALS LLC | 86211-116 | 86211-0116-10 |
| Doxycycline | Doxycycline 40 mg/1 | CapsuleOral | AiPing Pharmaceutical, Inc. | 11788-134 | 11788-0134-30 |
Other NDCs under ANDA 065053
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 | Sun Pharmaceutical Industries, Inc. | 63304-614 |
| Doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 63304-616 |
| Doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1988 |
| Doxycycline Monohydrate | Doxycycline 100 mg/1 | CapsuleOral | Direct_Rx | 72189-358 |