Prescription drug · NDA
Retin-A MICRO (Tretinoin) NDC 0187-5148
Tretinoin .8 mg/g · Gel · Topical · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-5148-02 | 0018751480200187514802 | 24 TUBE in 1 CARTON (0187-5148-02) / 2 g in 1 TUBEMarketed from Jan 28, 2014 | |
| 0187-5148-50 | 0018751485000187514850 | 1 BOTTLE, PUMP in 1 CARTON (0187-5148-50) / 50 g in 1 BOTTLE, PUMPMarketed from Jan 28, 2014 |
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)
- Retin-A MICRO
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — .8 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020475
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0187-5148_5eacf7df-7bdd-4401-ae28-2319c8757b4aSPL ID 5eacf7df-7bdd-4401-ae28-2319c8757b4aSPL set ID 08ab7e0c-1437-455f-815c-98904d96a289RxCUI 313453, 359050, 805370, 805372, 1488045, 1488047, 1987644, 1987646UNII 5688UTC01R
- 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
N400187514802followed by a unit qualifier and the quantityPackage 00187-5148-02. 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)
RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1)
Excerpt only. Read the full label for complete information.
About NDC 0187-5148
- What is NDC 0187-5148?
- 0187-5148 is the product NDC for Retin-A MICRO (tretinoin), Tretinoin .8 mg/g gel, listed with the FDA by Bausch Health US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Retin-A MICRO (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 Retin-A MICRO?
- 3 other product NDCs are listed under this name. See all Retin-A MICRO NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Retin-A MICRO products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Retin-A MICROtretinoin | Tretinoin .6 mg/g | GelTopical | Bausch Health US LLC | 0187-5146 | 00187-5146-0200187-5146-50 |
| Retin-A MICROtretinoin | Tretinoin .4 mg/g | GelTopical | Bausch Health US LLC | 0187-5144 | — |
| Retin-A MICROtretinoin | Tretinoin 1 mg/g | GelTopical | Bausch Health US LLC | 0187-5140 | — |
Other NDCs under NDA 020475
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 |
|---|---|---|---|---|
| Retin-A MICROtretinoin | Tretinoin 1 mg/g | GelTopical | Bausch Health US LLC | 0187-5140 |
| Retin-A MICROtretinoin | Tretinoin .4 mg/g | GelTopical | Bausch Health US LLC | 0187-5144 |
| Retin-A MICROtretinoin | Tretinoin .6 mg/g | GelTopical | Bausch Health US LLC | 0187-5146 |
| Tretinoin | Tretinoin 1 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-513 |
| Tretinoin | Tretinoin .4 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-514 |
| Tretinoin | Tretinoin .8 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-515 |