Prescription drug · ANDA
Clindamycin Phosphate and Tretinoin NDC 0472-1790
Clindamycin phosphate 12 mg/g; Tretinoin .25 mg/g · Gel · Topical · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0472-1790-30 | 0047217903000472179030 | 1 TUBE in 1 CARTON (0472-1790-30) / 30 g in 1 TUBEMarketed from Jul 5, 2016 | |
| 0472-1790-60 | 0047217906000472179060 | 1 TUBE in 1 CARTON (0472-1790-60) / 60 g in 1 TUBEMarketed from Jul 5, 2016 |
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)
- Clindamycin Phosphate and Tretinoin
- Generic name (nonproprietary)
- clindamycin phosphate and tretinoin
- Active ingredients
- Clindamycin phosphate — 12 mg/gTretinoin — .25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0472
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202564
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)Retinoids (Chemical structure)
- Identifiers
- Product ID 0472-1790_8d92b9da-5fea-4457-a757-a589d443fd7aSPL ID 8d92b9da-5fea-4457-a757-a589d443fd7aSPL set ID 79e1c8f6-59cd-4efa-9efa-0762d4b1a10cRxCUI 882548UNII EH6D7113I8, 5688UTC01R
- Pharmacologic class
- Lincosamide Antibacterial; Retinoid
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400472179030followed by a unit qualifier and the quantityPackage 00472-1790-30. 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)
Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0472-1790
- What is NDC 0472-1790?
- 0472-1790 is the product NDC for Clindamycin Phosphate and Tretinoin, Clindamycin phosphate 12 mg/g; Tretinoin .25 mg/g gel, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin Phosphate and Tretinoin.
- What is the active ingredient?
- Clindamycin phosphate, Tretinoin.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0472. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clindamycin Phosphate and Tretinoin?
- 1 other product NDC are listed under this name. See all Clindamycin Phosphate and Tretinoin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin Phosphate and Tretinoin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycin Phosphate and Tretinoin | Clindamycin phosphate 10 mg/g; Tretinoin .25 mg/g | GelTopical | Solaris Pharma Corporation | 73473-306 | 73473-0306-3073473-0306-60 |