Over-the-counter drug · ANDA
Effaclar (Adapalene) NDC 49967-591
Adapalene 1 mg/g · Gel · Topical · LOreal USA Products Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49967-591-01 | 4996705910149967059101 | 1 TUBE in 1 CARTON (49967-591-01) / 45 g in 1 TUBEMarketed from Aug 23, 2019 | |
| 49967-591-02 | 4996705910249967059102 | 1 TUBE in 1 CARTON (49967-591-02) / 3 g in 1 TUBEMarketed from Oct 22, 2019 |
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)
- Effaclar
- Generic name (nonproprietary)
- adapalene
- Active ingredients
- Adapalene — 1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- LOreal USA Products IncNDC labeler code 49967
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091314
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 49967-591_b42708ac-ccbb-4494-aeec-8a8acea67ca4SPL ID b42708ac-ccbb-4494-aeec-8a8acea67ca4SPL set ID a47b204a-3815-4a2b-9a7d-2c2b65b837bbRxCUI 307731UNII 1L4806J2QFUPC 3606000527553
- 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
N449967059101followed by a unit qualifier and the quantityPackage 49967-0591-01. 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)
Use • for the treatment of acne
Excerpt only. Read the full label for complete information.
About NDC 49967-591
- What is NDC 49967-591?
- 49967-591 is the product NDC for Effaclar (adapalene), Adapalene 1 mg/g gel, listed with the FDA by LOreal USA Products Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Effaclar (Adapalene).
- What is the active ingredient?
- Adapalene.
- Who is the labeler?
- LOreal USA Products Inc, NDC labeler code 49967. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Effaclar?
- 1 other product NDC are listed under this name. See all Effaclar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Effaclar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Effaclaradapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-592 | 49967-0592-0149967-0592-02 |
Other NDCs under ANDA 091314
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 |
|---|---|---|---|---|
| Adapalene | Adapalene 1 mg/g | GelTopical | Walgreens | 0363-0888 |
| Adapalene | Adapalene 1 mg/g | GelTopical | MEIJER, INC. | 41250-288 |
| Adapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-354 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-880 |
| Adapalene | Adapalene 1 mg/g | GelTopical | CVS Pharmacy | 69842-088 |
| Adapalene | Adapalene 1 mg/g | GelTopical | GLENMARK THERAPEUTICS INC., USA | 72657-158 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-216 |
| Adapaleneadaplane 0.1% | Adapalene .1 g/g | GelTopical | Acne Free, LLC | 80861-115 |
| Adapalene Geladaplaene | Adapalene .00036 g/g | GelTopical | Acne Free LLC | 80861-114 |
| Curist Acne Reliefadapalene | Adapalene .1 g/100g | GelTopical | Little Pharma, Inc. | 72559-015 |
| Effaclaradapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-592 |