Tretinoin
- Product NDC
- 10370-268
- 11-digit product format
- 103700268
- Labeler code
- 10370
- Product ID
- 10370-268_706a0d15-318d-404c-8a90-efab0237c7ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA201687
- Marketing category
- ANDA
- Marketing start
- 2012-10-24
- Substance
- TRETINOIN
- Active strength
- 10 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
- Tretinoin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRETINOIN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 199159 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10370-268-01 | Tretinoin | 100 in 1 BOTTLE | CAPSULE | 100 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRETINOIN | ACTIVE INGREDIENT | 5688UTC01R | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| TRETINOIN | ACTIVE INGREDIENT | 5688UTC01R | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| TRETINOIN | ACTIVE MOIETY | 5688UTC01R | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| TRETINOIN | ACTIVE MOIETY | 5688UTC01R | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10370-268 | TRETINOIN CAPSULE [ENDO USA, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20250327_9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9.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 |
|---|
| 10370-268-01 | 10370026801 | 100 CAPSULE in 1 BOTTLE (10370-268-01) | 100 capsule | 2012-10-24 | 0000-00-00 | No | No | Current |