Tretinoin
- Product NDC
- 21922-078
- 11-digit product format
- 219220078
- Labeler code
- 21922
- Product ID
- 21922-078_916137d0-edab-466c-8ec9-ffbe7b6cf162
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA217832
- Marketing category
- ANDA
- Marketing start
- 2026-03-26
- Substance
- TRETINOIN
- Active strength
- .5 mg/g
- 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 |
|---|---|
| TRETINOIN | .5 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 5688UTC01R |
| Rxcui | 106302, 106303, 198300 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60 | Product name | 6 | 20251124 |
| 1426d8f8-b7d5-4053-8554-613df00c0d86 | Product name | 2 | 20250616 |
| 0e7b8bf1-c46c-4de6-b26a-0c50e34364ec | Product name | 2 | 20250521 |
| e3af9708-3004-7392-4046-5311eaa8bab5 | Product name | 3 | 20221128 |
| 13e7e7e3-e885-4c79-af6d-dad1aedbb06e | Product name | 1 | 20220128 |
| 503b047e-e62d-4745-9011-522b13bc701b | Product name | 1 | 20181206 |
| 7d41caa2-0b5d-9b03-ab8d-84271de26ef4 | Product name | 2 | 20170314 |
| 50ca9ff5-82dd-9971-4f2c-5845a76a8572 | Product name | 2 | 20150818 |
| 0a8118e4-08c6-b395-9ddc-d3e425e0493a | Product name | 1 | 20140508 |
| 233bcb0a-cf40-b0a1-b346-c83ac2f43579 | Product name | 1 | 20140508 |
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21922-078-06 | Tretinoin | 45 g in 1 TUBE | CREAM | 45 | 4 | |
| 21922-078-06 | Tretinoin | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 21922-078-25 | Tretinoin | 20 g in 1 TUBE | CREAM | 20 | 4 | |
| 21922-078-25 | Tretinoin | 1 in 1 CARTON | CREAM | 1 | 4 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 106302 | tretinoin 0.025 % Topical Cream | PSN | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 106303 | tretinoin 0.05 % Topical Cream | PSN | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 198300 | tretinoin 0.1 % Topical Cream | PSN | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 106302 | tretinoin 0.25 MG/ML Topical Cream | SCD | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 106303 | tretinoin 0.5 MG/ML Topical Cream | SCD | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 198300 | tretinoin 1 MG/ML Topical Cream | SCD | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 106302 | tretinoin 0.025 % Topical Cream | SY | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 106303 | tretinoin 0.05 % Topical Cream | SY | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
| 198300 | tretinoin 0.1 % Topical Cream | SY | 5e3fb8ea-234c-4be2-95a7-d139e069cf98 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 21922-078-06 | 21922007806 | 1 TUBE in 1 CARTON (21922-078-06) / 45 g in 1 TUBE | 1 tube | 2026-03-26 | No | No | Historical |
| 21922-078-25 | 21922007825 | 1 TUBE in 1 CARTON (21922-078-25) / 20 g in 1 TUBE | 1 tube | 2026-03-26 | No | No | Historical |