Prescription drug · ANDA
Tretinoin (Microsphere) (Tretinoin) NDC 68308-777
Tretinoin .8 mg/g · Gel · Topical · Mayne Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68308-777-50 | 6830807775068308077750 | 1 BOTTLE, PUMP in 1 CARTON (68308-777-50) / 50 g in 1 BOTTLE, PUMPMarketed from Oct 25, 2024 |
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 (Microsphere)
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — .8 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Mayne PharmaNDC labeler code 68308
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215609
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 68308-777_7c0103a9-019d-4bc4-b4f5-df7d89bfd11dSPL ID 7c0103a9-019d-4bc4-b4f5-df7d89bfd11dSPL set ID ed2103ee-c9d5-4b3d-b525-318cf67be050RxCUI 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
N468308077750followed by a unit qualifier and the quantityPackage 68308-0777-50. 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 a retinoid indicated for topical application in the treatment of acne vulgaris. Tretinoin gel (microsphere) is a retinoid, indicated for topical treatment of acne vulgaris. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68308-777
- What is NDC 68308-777?
- 68308-777 is the product NDC for Tretinoin (Microsphere) (tretinoin), Tretinoin .8 mg/g gel, listed with the FDA by Mayne Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tretinoin (Microsphere) (Tretinoin).
- What is the active ingredient?
- Tretinoin.
- Who is the labeler?
- Mayne Pharma, NDC labeler code 68308. 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 (Microsphere)?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 215609
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 .6 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-042 |
| Tretinoin | Tretinoin .8 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-043 |
| Tretinoin | Tretinoin .8 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2303 |