Prescription drug · ANDA
doxycycline NDC 65841-823
Doxycycline 100 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)65841-823Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0823Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-823-01 | 6584108230165841082301 | 100 CAPSULE in 1 BOTTLE (65841-823-01)Marketed from Mar 14, 2016 | |
| 65841-823-05 | 6584108230565841082305 | 500 CAPSULE in 1 BOTTLE (65841-823-05)Marketed from Mar 14, 2016 | |
| 65841-823-06 | 6584108230665841082306 | 30 CAPSULE in 1 BOTTLE (65841-823-06)Marketed from Mar 14, 2016 | |
| 65841-823-10 | 6584108231065841082310 | 1000 CAPSULE in 1 BOTTLE (65841-823-10)Marketed from Mar 14, 2016 | |
| 65841-823-16 | 6584108231665841082316 | 90 CAPSULE in 1 BOTTLE (65841-823-16)Marketed from Mar 14, 2016 | |
| 65841-823-18 | 6584108231865841082318 | 50 CAPSULE in 1 BOTTLE (65841-823-18)Marketed from Mar 14, 2016 | |
| 65841-823-21 | 6584108232165841082321 | 250 CAPSULE in 1 BOTTLE (65841-823-21)Marketed from Mar 14, 2016 | |
| 65841-823-77 | 6584108237765841082377 | 10 BLISTER PACK in 1 CARTON (65841-823-77) / 10 CAPSULE in 1 BLISTER PACK (65841-823-30)Marketed from Mar 14, 2016 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- 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 65841-823_d9de3252-a876-482e-be60-0a47eb985aa8SPL ID d9de3252-a876-482e-be60-0a47eb985aa8SPL set ID aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9RxCUI 700408, 1649401, 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
N465841082301followed by a unit qualifier and the quantityPackage 65841-0823-01. 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 .
About NDC 65841-823
- What is NDC 65841-823?
- 65841-823 is the product NDC for doxycycline, Doxycycline 100 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 8 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?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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?
- 136 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 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 | Safecor Health, LLC | 48433-158 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-159 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4833 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | AvPAK | 50268-280 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | AvPAK | 50268-281 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-712 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-821 |
| doxycycline | Doxycycline 75 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-822 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1260 |
| 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 50 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-782 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1479 |
| 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 Monohydrate | Doxycycline 100 mg/1 | CapsuleOral | DIRECT RX | 61919-624 |