Prescription drug · ANDA
Tretinoin NDC 72162-1220
Tretinoin 10 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1220-1 | 7216212200172162122001 | 100 CAPSULE in 1 BOTTLE (72162-1220-1)Marketed from Feb 9, 2024 | |
| 72162-1220-3 | 7216212200372162122003 | 30 CAPSULE in 1 BOTTLE (72162-1220-3)Marketed from Feb 9, 2024 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201687
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 72162-1220_f882a775-5ca1-4aeb-868e-ab77e0f31875SPL ID f882a775-5ca1-4aeb-868e-ab77e0f31875SPL set ID 7a7974c7-8b6c-41ae-9a48-a08a1439087aRxCUI 199159UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472162122001followed by a unit qualifier and the quantityPackage 72162-1220-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relaps…
Excerpt only. Read the full label for complete information.
About NDC 72162-1220
- What is NDC 72162-1220?
- 72162-1220 is the product NDC for Tretinoin, Tretinoin 10 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 72162. 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 201687
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 10 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6867 |
| Tretinoin | Tretinoin 10 mg/1 | CapsuleOral | Par Health USA, LLC | 10370-268 |
| Tretinoin | Tretinoin 10 mg/1 | CapsuleOral | American Health Packaging | 68084-075 |