Prescription drug · NDA AUTHORIZED GENERIC
Tretinoin NDC 68682-515
Tretinoin .8 mg/g · Gel · Topical · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-515-95 | 6868205159568682051595 | 1 BOTTLE, PUMP in 1 CARTON (68682-515-95) / 50 g in 1 BOTTLE, PUMPMarketed from Dec 1, 2023 |
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 — .8 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Oceanside PharmaceuticalsNDC labeler code 68682
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020475
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 68682-515_c4ef7e4d-9c2e-4022-b7ab-b55962c1a58aSPL ID c4ef7e4d-9c2e-4022-b7ab-b55962c1a58aSPL set ID d3c528d2-429d-4f37-9ebf-eee8b9fd3050RxCUI 313453, 359050, 1488045UNII 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
N468682051595followed by a unit qualifier and the quantityPackage 68682-0515-95. 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)
Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Tretinoin Gel Microsphere 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 68682-515
- What is NDC 68682-515?
- 68682-515 is the product NDC for Tretinoin, Tretinoin .8 mg/g gel, listed with the FDA by Oceanside Pharmaceuticals. It has 1 package NDC, 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?
- Oceanside Pharmaceuticals, NDC labeler code 68682. 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 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 |
| Retin-A MICROtretinoin | Tretinoin .8 mg/g | GelTopical | Bausch Health US LLC | 0187-5148 |
| Tretinoin | Tretinoin 1 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-513 |
| Tretinoin | Tretinoin .4 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-514 |