Tretinoin
- Product NDC
- 0378-8093
- 11-digit product format
- 003788093
- Labeler code
- 0378
- Product ID
- 0378-8093_c9f92ca9-5c8e-4a76-9304-a92bc552246b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020475
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-12-17
- Marketing end
- 0000-00-00
- Substance
- TRETINOIN
- Active strength
- 1 mg/g
- Pharmacologic classes
- Retinoid [EPC],Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8093 | TRETINOIN GEL [MYLAN PHARMACEUTICALS INC.] | 9 | Legacy NDC | 20240824_ff10a007-5814-4794-8ce3-da5cc85fca85.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-8093-20 | 00378809320 | 1 TUBE in 1 CARTON (0378-8093-20) > 20 g in 1 TUBE | 1 tube | 2018-12-17 | 0000-00-00 | No | No | Current |
| 0378-8093-45 | 00378809345 | 1 TUBE in 1 CARTON (0378-8093-45) > 45 g in 1 TUBE | 1 tube | 2018-12-17 | 0000-00-00 | No | No | Current |
| 0378-8093-50 | 00378809350 | 1 BOTTLE, PUMP in 1 CARTON (0378-8093-50) > 50 g in 1 BOTTLE, PUMP | | 2019-10-16 | 0000-00-00 | No | No | Current |