Doxepin Hydrochloride
- Product NDC
- 69238-1166
- 11-digit product format
- 692381166
- Labeler code
- 69238
- Product ID
- 69238-1166_0d905a6d-9f40-435d-a39a-f97ce7264b15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA207482
- Marketing category
- ANDA
- Marketing start
- 2017-06-28
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 10 mg/1
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000048, 1000058, 1000070, 1000076, 1000097 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1166-1 | Doxepin Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 15 |
| 69238-1166-3 | Doxepin Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 15 |
| 69238-1166-9 | Doxepin Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1166 | DOXEPIN HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] | 15 | Current NDC, Legacy NDC, 3 package rows | 20241210_20bfb8af-7933-4e5c-a2b5-010659d9125b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-1166-1 | 69238116601 | 1000 CAPSULE in 1 BOTTLE (69238-1166-1) | 1000 capsule | 2017-06-28 | 0000-00-00 | No | No | Current |
| 69238-1166-3 | 69238116603 | 30 CAPSULE in 1 BOTTLE (69238-1166-3) | 30 capsule | 2017-06-28 | 0000-00-00 | No | No | Current |
| 69238-1166-9 | 69238116609 | 90 CAPSULE in 1 BOTTLE (69238-1166-9) | 90 capsule | 2017-06-28 | 0000-00-00 | No | No | Current |