Prescription drug · NDA
Oracea (doxycycline) NDC 0299-3822
Doxycycline 40 mg/1 · Capsule · Oral · Galderma Laboratories, L.P.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0299-3822-30 | 00299382230 | 30 CAPSULE in 1 BOTTLE (0299-3822-30)Marketed from May 14, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Oracea
- Generic name (nonproprietary)
- doxycycline
- Active ingredients
- Doxycycline — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Galderma Laboratories, L.P.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050805
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0SPL ID 67eef1b6-593a-4277-abd3-f3e60e7557b0SPL set ID aa15c93a-ff4c-447a-8a21-96da506d8997RxCUI 901399, 901401UNII 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
N400299382230followed by a unit qualifier and the quantityPackage 00299-3822-30. 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)
ORACEA 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 ORACEA for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. ( 1.2 ) ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. ( 1.2 ) 1.1 Indication ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of r…
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Doxycycline | Doxycycline 40 mg/1 | CapsuleOral | Mayne Pharma Inc. | 68308-668 |