Isotretinoin
- Product NDC
- 0832-8303
- 11-digit product format
- 008328303
- Labeler code
- 0832
- Product ID
- 0832-8303_4abc427d-939a-2bc9-e063-6294a90ae582
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA076485
- Marketing category
- ANDA
- Marketing start
- 2015-08-26
- Substance
- ISOTRETINOIN
- Active strength
- 30 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
- Isotretinoin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOTRETINOIN | 30 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 |
|---|
| 0832-8303-30 | Isotretinoin | 3 in 1 BOX | CAPSULE, LIQUID FILLED | 3 | | 3 |
| 0832-8303-89 | Isotretinoin | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-8303 | ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC] | 1 | Current NDC, 2 package rows | 20230610_c369e1c3-90c5-4768-9741-56c62253a2c4.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 |
|---|
| 0832-8303-30 | 00832830330 | 3 BLISTER PACK in 1 BOX (0832-8303-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8303-89) | 3 blister pack | 2023-06-06 | No | No | Current |
| 0832-8303-89 | 00832830389 | 10 in 1 BLISTER PACK | | | | | Historical |