Isotretinoin
- Product NDC
- 68308-782
- 11-digit product format
- 683080782
- Labeler code
- 68308
- Product ID
- 68308-782_1bcfc61e-1b15-60e8-e063-6294a90ab074
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Mayne Pharma
- Application
- ANDA076485
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- Substance
- ISOTRETINOIN
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 197845, 403930 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68308-782-01 | Isotretinoin | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 4 |
| 68308-782-30 | Isotretinoin | 3 in 1 BOX | CAPSULE, LIQUID FILLED | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68308-782 | ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA] | 4 | Current NDC, 2 package rows | 20240628_0114567b-3bac-490d-b9eb-03a6c5d90935.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68308-782-01 | 68308078201 | 10 in 1 BLISTER PACK | | | | | Historical |
| 68308-782-30 | 68308078230 | 3 BLISTER PACK in 1 BOX (68308-782-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-782-01) | 3 blister pack | 2023-12-01 | No | No | Historical |