Isotretinoin
- Product NDC
- 57664-022
- 11-digit product format
- 576640022
- Labeler code
- 57664
- Product ID
- 57664-022_0e924cf6-5375-28c4-e063-6294a90a4ac4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA021951
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-12-29
- Substance
- ISOTRETINOIN
- Active strength
- 25 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isotretinoin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOTRETINOIN | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 197845, 403930, 1547561, 1547565 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-022-97 | Isotretinoin | 3 in 1 BOX | CAPSULE | 3 | | 2 |
| 57664-022-98 | Isotretinoin | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-022 | ISOTRETINOIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240110_b44200ba-6672-4ea7-b151-7caec3f53c9c.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 |
|---|
| 57664-022-97 | 57664002297 | 3 BLISTER PACK in 1 BOX (57664-022-97) / 10 CAPSULE in 1 BLISTER PACK (57664-022-98) | 3 blister pack | 2020-12-29 | 0000-00-00 | No | No | Current |
| 57664-022-98 | 57664002298 | 10 in 1 BLISTER PACK | | | | | | Historical |