DOXEPIN HYDROCHLORIDE
- Product NDC
- 51672-4217
- 11-digit product format
- 516724217
- Labeler code
- 51672
- Product ID
- 51672-4217_f71ace15-9ee2-4547-88fa-f787496b7dc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXEPIN HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA213063
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- Marketing end
- 0000-00-00
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 51672-4217 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 51672-4217 | 51672-4217-1 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51672-4217 | 51672-4217-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213063-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-01 | ||
| A213063-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-01 | ||
| A213063-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-01 | ||
| A213063-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-01 | ||
| A213063-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-01 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2020-07-01 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A213063-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213063-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213063-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213063-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213063-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213063-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213063-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213063-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213063-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213063-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213063-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213063-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213063-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213063-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213063-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213063-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213063-005 | AB | 1 | d06236e962d9… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f6fcd62d-384f-5faa-05d7-c5d5903c6c43 | Product name | 4 | 20250515 |
| 3d5463a5-d368-9c2b-b40c-0f2b688e406e | Product name | 9 | 20240805 |
| 750bc85a-c69c-4145-a865-3f1124677d16 | Product name | 3 | 20240321 |
| eda77195-5c17-5c7f-a6a7-8c80d2f8ae5f | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-4217-1 | EA - Each | 51672-4217 | eeb6b329-b1a9-4d6d-aab3-9c4fd20b56b7 | 1 | 2020-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-4217 | DOXEPIN HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | Legacy NDC | 20200707_e5f35807-3db1-4387-8c37-693d9170b51b.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Doxepin HCL | DOXEPIN HCL | Direct_Rx | dea965fe-6b54-bbf0-e053-2a95a90a1003 | 2025-01-22 | Warnings, Adverse reactions | 213063 ANDA213063 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | direct rx | b56cdaee-6187-c763-e053-2995a90acc3f | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 213063 ANDA213063 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f900bac4-02f2-6bf3-e053-6394a90a2161 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 213063 ANDA213063 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | A-S Medication Solutions | 55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2 | 2024-07-30 | Boxed warning, Warnings, Adverse reactions | 213063 ANDA213063 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000048 | doxepin HCl 10 MG Oral Capsule | PSN | dea965fe-6b54-bbf0-e053-2a95a90a1003 | 3 |
| 1000048 | doxepin 10 MG Oral Capsule | SCD | dea965fe-6b54-bbf0-e053-2a95a90a1003 | 3 |
| 1000048 | doxepin (as doxepin HCl) 10 MG Oral Capsule | SY | dea965fe-6b54-bbf0-e053-2a95a90a1003 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51672-4217-1 | 51672421701 | 100 CAPSULE in 1 BOTTLE (51672-4217-1) | 100 capsule | 2020-07-01 | 0000-00-00 | No | No | Current |