Prescription drug · NDA AUTHORIZED GENERIC
Doxycycline NDC 68308-668
Doxycycline 40 mg/1 · Capsule · Oral · Mayne Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68308-668-30 | 6830806683068308066830 | 30 CAPSULE in 1 BOTTLE (68308-668-30)Marketed from Feb 27, 2023 |
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 — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mayne Pharma Inc.NDC labeler code 68308
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050805
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 68308-668_4600dc6a-950d-4d84-aed9-da01fbd0db8bSPL ID 4600dc6a-950d-4d84-aed9-da01fbd0db8bSPL set ID 0e6b3e17-aeee-4910-8e94-c7ac925b9ccaRxCUI 901399UNII 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
N468308066830followed by a unit qualifier and the quantityPackage 68308-0668-30. 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)
Doxycycline is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ( 1.1 ) Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use Doxycycline for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. ( 1.2 ) Doxycycline has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. ( 1.2 ) 1.1 Indication Doxycycline is indicated for the treatment of only inflammatory lesions (papule…
Excerpt only. Read the full label for complete information.
About NDC 68308-668
- What is NDC 68308-668?
- 68308-668 is the product NDC for Doxycycline, Doxycycline 40 mg/1 capsule, listed with the FDA by Mayne Pharma Inc.. It has 1 package NDC, 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?
- Mayne Pharma Inc., NDC labeler code 68308. 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 NDA 050805
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 |
|---|---|---|---|---|
| Oraceadoxycycline | Doxycycline 40 mg/1 | CapsuleOral | Galderma Laboratories, L.P. | 0299-3822 |