DOXEPIN HYDROCHLORIDE
- Product NDC
- 46708-637
- 11-digit product format
- 467080637
- Labeler code
- 46708
- Product ID
- 46708-637_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXEPIN HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA215076
- Marketing category
- ANDA
- Marketing start
- 2021-04-23
- 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 |
|---|---|---|---|---|---|---|---|
| A215076-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | |
| A215076-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | |
| A215076-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | |
| A215076-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | |
| A215076-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215076-001 | AB |
| A215076-002 | AB |
| A215076-003 | AB |
| A215076-004 | AB |
| A215076-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2021-04-21 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215076-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215076-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215076-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215076-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215076-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215076-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215076-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215076-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215076-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215076-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215076-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215076-005 | AB | 1 | 2680178bc6a6… |
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 |
|---|---|
| 842b595b-dc54-4898-a178-1d2241cc065f | 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 |
|---|---|---|---|---|---|---|
| 46708-637-31 | DOXEPIN HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE | 100 | 2 | |
| 46708-637-91 | DOXEPIN HYDROCHLORIDE | 1000 in 1 BOTTLE | CAPSULE | 1000 | 2 |
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 | Bryant Ranch Prepack | 09a70f17-f934-4b4b-9277-6351d906ab47 | 2025-10-24 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 21dc77be-23af-4a1f-b189-dfee8ae2f894 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 4920401a-cde5-404b-82aa-c3c0e8911065 | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 06e027bb-516d-4a1d-b5a0-a66c051eb367 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 19c8ad61-4e4f-4c59-b196-34a4e470459f | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| Doxepin HCL | DOXEPIN HCL | Direct_rx | 21c64f9f-cee2-60b0-e063-6294a90ae97e | 2024-09-10 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 214bae5d-36e2-47ae-e063-6294a90a7ddd | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 1cec730e-3218-ddf6-e063-6294a90a916e | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | A-S Medication Solutions | 890248d7-73b1-4ed3-b252-85775defdf34 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 842b595b-dc54-4898-a178-1d2241cc065f | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | 215076 ANDA215076 46708-637 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 46708-637-31 | 46708063731 | 100 CAPSULE in 1 BOTTLE (46708-637-31) | 100 capsule | 2021-04-23 | 0000-00-00 | No | No | Current |
| 46708-637-91 | 46708063791 | 1000 CAPSULE in 1 BOTTLE (46708-637-91) | 1000 capsule | 2021-04-23 | 0000-00-00 | No | No | Current |