Prescription drug · ANDA
Tretinoin NDC 16714-249
Tretinoin .5 mg/g · Cream · Topical · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-249-01 | 1671402490116714024901 | 1 TUBE in 1 CARTON (16714-249-01) / 20 g in 1 TUBEMarketed from Feb 25, 2022 | |
| 16714-249-02 | 1671402490216714024902 | 1 TUBE in 1 CARTON (16714-249-02) / 45 g in 1 TUBEMarketed from Feb 25, 2022 |
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)
- Tretinoin
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- NORTHSTAR RX LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211644
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 16714-249_39809045-c9fe-0fc5-e063-6394a90a60b0SPL ID 39809045-c9fe-0fc5-e063-6394a90a60b0SPL set ID 2e508351-eca3-427e-8d16-e840a84db0f5RxCUI 106303UNII 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
N416714024901followed by a unit qualifier and the quantityPackage 16714-0249-01. 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)
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.
About NDC 16714-249
- What is NDC 16714-249?
- 16714-249 is the product NDC for Tretinoin, Tretinoin .5 mg/g cream, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tretinoin.
- What is the active ingredient?
- Tretinoin.
- Who is the labeler?
- NORTHSTAR RX LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tretinoin?
- 68 other product NDCs are listed under this name. See all Tretinoin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Tretinoin | Tretinoin .25 mg/g | CreamTopical | Zydus Lifesciences Limited | 70771-1933 | 70771-1933-0270771-1933-04 |
| Tretinoin | Tretinoin .25 mg/g | CreamTopical | Viona Pharmaceuticals Inc | 72578-155 | 72578-0155-0872578-0155-09 |
| Tretinoin | Tretinoin .5 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-808 | 46708-0808-0046708-0808-20 |
| Tretinoin | Tretinoin .5 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-808 | 62332-0808-2062332-0808-45 |
| Tretinoin | Tretinoin .8 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2323 | 69238-2323-01 |
| Tretinoin | Tretinoin .6 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-042 | 21922-0042-40 |
| Tretinoin | Tretinoin .5 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-078 | 21922-0078-0621922-0078-25 |
| Tretinoin | Tretinoin 1 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-077 | 21922-0077-0621922-0077-25 |
| Tretinoin | Tretinoin .25 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4069 | 68788-4069-02 |
| Tretinoin | Tretinoin .25 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-809 | 46708-0809-2046708-0809-45 |
Other NDCs under ANDA 211644
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 .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-6819 |
| Tretinoin | Tretinoin .5 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1394 |
| Tretinoin | Tretinoin .5 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-3865 |