TRETINOIN
- Product NDC
- 50090-3058
- 11-digit product format
- 500903058
- Labeler code
- 50090
- Product ID
- 50090-3058_751edf37-8105-49e3-8621-475a5543193b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tretinoin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA075265
- Marketing category
- ANDA
- Marketing start
- 2017-04-26
- Substance
- TRETINOIN
- Active strength
- .5 mg/g
- 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
- TRETINOIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRETINOIN | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 106302, 106303, 198300 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-3058-0 | 2024-10-23 | C162847 | 48780-1 | 9d75b9d1-13aa-f424-e053-dadaa90a57ce | Tretinoin Gel, USP and Tretinoin Cream, USP |
| 50090-3058-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-13aa-f424-e053-dadaa90a57ce | Tretinoin Gel, USP and Tretinoin Cream, USP |
| 50090-3058-0 | 2021-03-01 | C162847 | 48780-1 | 9d75b9d1-13aa-f424-e053-dadaa90a57ce | Tretinoin Gel, USP and Tretinoin Cream, USP |
| 50090-3058-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-13aa-f424-e053-dadaa90a57ce | Tretinoin Gel, USP and Tretinoin Cream, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3058-0 | TRETINOIN | 45 g in 1 TUBE | CREAM | 45 | | 24 |
| 50090-3058-0 | TRETINOIN | 1 in 1 CARTON | CREAM | 1 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3058 | TRETINOIN CREAM [A-S MEDICATION SOLUTIONS] | 24 | Current NDC, Legacy NDC, 2 package rows | 20241025_0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5.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 |
|---|
| 50090-3058-0 | 50090305800 | 1 TUBE in 1 CARTON (50090-3058-0) / 45 g in 1 TUBE | 1 tube | 2017-06-15 | 0000-00-00 | No | No | Current |