Doxepin Hydrochloride
- Product NDC
- 69238-1733
- 11-digit product format
- 692381733
- Labeler code
- 69238
- Product ID
- 69238-1733_f44f392e-0f43-4e5d-a2c4-0b15387d67ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA212357
- Marketing category
- ANDA
- Marketing start
- 2023-08-21
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 50 mg/g
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxepin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXEPIN HYDROCHLORIDE | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000091 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1733-6 | Doxepin Hydrochloride | 1 in 1 CARTON | CREAM | 1 | | 8 |
| 69238-1733-6 | Doxepin Hydrochloride | 45 g in 1 TUBE | CREAM | 45 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1733 | DOXEPIN HYDROCHLORIDE CREAM [AMNEAL PHARMACEUTICALS NY LLC] | 8 | Current NDC, 2 package rows | 20250427_dd8d5edd-7b08-4061-86e6-c4179da89c0d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-1733-6 | 69238173306 | 1 TUBE in 1 CARTON (69238-1733-6) / 45 g in 1 TUBE | 1 tube | 2023-08-21 | No | No | Current |