Doxepin Hydrochloride
- Product NDC
- 48433-036
- 11-digit product format
- 484330036
- Labeler code
- 48433
- Product ID
- 48433-036_4c4c90ec-fb2d-e45d-e063-6294a90a419a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxepin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA070791
- Marketing category
- ANDA
- Marketing start
- 2026-02-23
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxepin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXEPIN HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000048, 1000058, 1000070, 1000076 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-036-01 | Doxepin Hydrochloride | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 2 |
| 48433-036-20 | Doxepin Hydrochloride | 100 in 1 CARTON | CAPSULE | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-036-01 | 48433003601 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-036-20 | 48433003620 | 100 BLISTER PACK in 1 CARTON (48433-036-20) / 1 CAPSULE in 1 BLISTER PACK (48433-036-01) | 100 blister pack | 2026-02-23 | No | No | Historical |