Doxepin Hydrochloride
- Product NDC
- 59651-173
- 11-digit product format
- 596510173
- Labeler code
- 59651
- Product ID
- 59651-173_5b5efe70-cce2-4950-94f0-d3aa869e442e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA211603
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211603-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211603-001 | AB |
| A211603-002 | AB |
| A211603-003 | AB |
| A211603-004 | AB |
| A211603-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211603-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-005 | AB | 1 | 03ed91905a0d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxepin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXEPIN HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3U9A0FE9N5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f3c242dd-426e-4c69-8f21-2645361d5f27 | Available on FDA.report |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59651-173-01 | Doxepin Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-173-01 | EA - Each | 59651-173 | d627f3e6-6688-41aa-a1ef-1942a05f8c36 | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
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 Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1496dfc1-de50-471c-be87-1f1e2b70ab5a | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Aurobindo Pharma Limited | f3c242dd-426e-4c69-8f21-2645361d5f27 | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 59651-173 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2bf7d838-6274-4d8a-91cb-b27e1e81d273 | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9ee26b24-7121-3107-e053-2995a90ac61c | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Proficient Rx LP | 6ce7fde2-2d47-4238-9beb-555d352f4657 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Proficient Rx LP | e98f371e-f7fe-4c8f-9491-6eb4c53d43ad | 2021-02-01 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59651-173-01 | 59651017301 | 100 CAPSULE in 1 BOTTLE (59651-173-01) | 100 capsule | 2019-03-27 | 0000-00-00 | No | No | Current |