ACCUTANE
- Product NDC
- 72143-254
- 11-digit product format
- 721430254
- Labeler code
- 72143
- Product ID
- 72143-254_499b3a69-1651-0f27-e063-6294a90a49eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOTRETINOIN
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- JG Pharma Inc.
- Application
- ANDA202099
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- Substance
- ISOTRETINOIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACCUTANE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOTRETINOIN | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72143-254-30 | ACCUTANE | 3 in 1 CARTON | CAPSULE, GELATIN COATED | 3 | | 3 |
| 72143-254-30 | ACCUTANE | 10 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72143-254 | ACCUTANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [JG PHARMA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231221_5b524a51-a16b-496e-b764-11c98c479c36.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72143-254-30 | 72143025430 | 3 BLISTER PACK in 1 CARTON (72143-254-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK | 3 blister pack | 2022-08-01 | 0000-00-00 | No | No | Current |