Doxepin Hydrochloride
- Product NDC
- 71921-164
- 11-digit product format
- 719210164
- Labeler code
- 71921
- Product ID
- 71921-164_ccbb860e-6367-5114-e053-2a95a90abfb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA213474
- Marketing category
- ANDA
- Marketing start
- 2021-05-01
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 50 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 | 50 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 |
|---|
| 71921-164-01 | Doxepin Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71921-164 | DOXEPIN HYDROCHLORIDE CAPSULE [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20210925_b787a283-f882-e1f0-e053-2a95a90a8975.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 |
|---|
| 71921-164-01 | 71921016401 | 100 CAPSULE in 1 BOTTLE (71921-164-01) | 100 capsule | 2021-05-01 | 0000-00-00 | No | No | Current |