Doxepin Hydrochloride
- Product NDC
- 59746-704
- 11-digit product format
- 597460704
- Labeler code
- 59746
- Product ID
- 59746-704_71faef93-5aa0-4d3b-a039-adf3bc8967c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- JUBILANT CADISTA PHARMACEUTICALS INC.
- Application
- ANDA215483
- Marketing category
- ANDA
- Marketing start
- 2021-12-01
- Marketing end
- 0000-00-00
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 59746-704 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-704 | 59746-704-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-704 | 59746-704-05 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-704 | 59746-704-90 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A215483-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | | 2022-03-14 |
| A215483-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | | 2022-03-14 |
| A215483-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | | 2022-03-14 |
| A215483-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | | 2022-03-14 |
| A215483-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | | 2022-03-14 |
Therapeutic equivalence codes#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59746-704 | DOXEPIN HYDROCHLORIDE CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20220317_47bf6f58-627c-4955-a835-ce0556188906.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59746-704-01 | 59746070401 | 100 CAPSULE in 1 BOTTLE, PLASTIC (59746-704-01) | 100 capsule | 2021-12-01 | 0000-00-00 | No | No | Current |
| 59746-704-05 | 59746070405 | 500 CAPSULE in 1 BOTTLE, PLASTIC (59746-704-05) | 500 capsule | 2021-12-01 | 0000-00-00 | No | No | Current |
| 59746-704-90 | 59746070490 | 90 CAPSULE in 1 BOTTLE, PLASTIC (59746-704-90) | 90 capsule | 2021-12-01 | 0000-00-00 | No | No | Current |