Prescription drug · NDA
Renova (Tretinoin) NDC 0187-5150
Tretinoin .2 mg/g · Cream · Topical · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-5150-02 | 0018751500200187515002 | 1 TUBE in 1 CARTON (0187-5150-02) / 2 g in 1 TUBEMarketed from Aug 31, 2000 | |
| 0187-5150-20 | 0018751502000187515020 | 1 TUBE in 1 CARTON (0187-5150-20) / 20 g in 1 TUBEMarketed from Aug 31, 2000 | |
| 0187-5150-40 | 0018751504000187515040 | 1 TUBE in 1 CARTON (0187-5150-40) / 40 g in 1 TUBEMarketed from Aug 31, 2000 | |
| 0187-5150-44 | 0018751504400187515044 | 1 BOTTLE, PUMP in 1 CARTON (0187-5150-44) / 44 g in 1 BOTTLE, PUMPMarketed from Aug 31, 2000 | |
| 0187-5150-60 | 0018751506000187515060 | 1 TUBE in 1 CARTON (0187-5150-60) / 60 g in 1 TUBEMarketed from Aug 31, 2000 |
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)
- Renova
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — .2 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021108
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0187-5150_440beed5-a673-423d-84e8-4f3432c37ee8SPL ID 440beed5-a673-423d-84e8-4f3432c37ee8SPL set ID 9f0a0e8d-1051-48a4-80c5-1bd260dd9c36RxCUI 252265, 846955UNII 5688UTC01RUPC 0301875150402
- Pharmacologic class
- 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
N400187515002followed by a unit qualifier and the quantityPackage 00187-5150-02. 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 understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the …
Excerpt only. Read the full label for complete information.
About NDC 0187-5150
- What is NDC 0187-5150?
- 0187-5150 is the product NDC for Renova (tretinoin), Tretinoin .2 mg/g cream, listed with the FDA by Bausch Health US LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Renova (Tretinoin).
- What is the active ingredient?
- Tretinoin.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Renova?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.