Tretinoin
- Product NDC
- 46708-808
- Requested package NDC
- 46708-808-00
- 11-digit product format
- 467080808
- Labeler code
- 46708
- Product ID
- 46708-808_2fb4d13d-eeae-4605-adf6-41b96027b98c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA214590
- Marketing category
- ANDA
- Marketing start
- 2026-06-11
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214590-001 | TRETINOIN | TRETINOIN | 0.05% | CREAM / TOPICAL | AB1 | 2026-06-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214590-001 | AB1 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214590-001 | TRETINOIN | 0.05% | CREAM / TOPICAL | AB1 | 2026-06-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A214590-001 | TRETINOIN | 0.05% | CREAM / TOPICAL | AB1 | 2026-06-11 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214590-001 | TRETINOIN | 0.05% | CREAM / TOPICAL | AB1 | 2026-06-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214590-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A214590-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214590-001 | AB1 | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tretinoin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRETINOIN | .5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5688UTC01R | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 106303 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5304df69-5d29-48f5-8227-80c7a6f12e6d | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tretinoin | TRETINOIN | Alembic Pharmaceuticals Limited | 5304df69-5d29-48f5-8227-80c7a6f12e6d | 2026-07-01 | Adverse reactions | 214590 ANDA214590 46708-808-00 46708-808 46708080800 |
| Tretinoin | TRETINOIN | Alembic Pharmaceuticals Inc. | 49e542a3-57cc-482f-9118-4174c80742dd | 2026-06-26 | Adverse reactions | 214590 ANDA214590 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 46708-808-00 | 46708080800 | 1 TUBE in 1 CARTON (46708-808-00) / 45 g in 1 TUBE | 1 tube | 2026-06-11 | No | No | Current |