Prescription drug · ANDA
Tretinoin NDC 50090-4347
Tretinoin 1 mg/g · Cream · Topical · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4347-0 | 50090434700 | 1 TUBE in 1 CARTON (50090-4347-0) / 45 g in 1 TUBEMarketed from Jun 11, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tretinoin
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211645
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 50090-4347_30e66646-8fed-4a3b-acc9-2028c00d5da8SPL ID 30e66646-8fed-4a3b-acc9-2028c00d5da8SPL set ID da206984-4ded-4d5c-8a23-323920466a5fRxCUI 198300UNII 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
N450090434700followed by a unit qualifier and the quantityPackage 50090-4347-00. 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 Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211645
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 |
|---|---|---|---|---|
| Tretinoin | Tretinoin 1 mg/g | CreamTopical | NORTHSTAR RX LLC | 16714-250 |
| Tretinoin | Tretinoin 1 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-3889 |
| Tretinoin | Tretinoin 1 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1395 |
| Tretinoin | Tretinoin 1 mg/g | CreamTopical | NuCare Pharmaceuticals, Inc. | 68071-3826 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.