Doxepin Hydrochloride
- Product NDC
- 48433-035
- Requested package NDC
- 48433-035-20
- 11-digit product format
- 484330035
- Labeler code
- 48433
- Product ID
- 48433-035_4c4c90ec-fb2d-e45d-e063-6294a90a419a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxepin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA070791
- Marketing category
- ANDA
- Marketing start
- 2026-02-23
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070791-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | |
| A070791-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | |
| A070791-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 |
| A070791-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | |
| A070791-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A070791-001 | AB |
| A070791-002 | AB |
| A070791-003 | AB |
| A070791-004 | AB |
| A070791-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-001 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1986-05-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1986-05-13 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070791-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070791-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070791-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070791-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A070791-005 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070791-005 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070791-005 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070791-005 | AB | 1 | 1e350fbaab3a… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | c577af7c-2405-4454-a169-5b6a4fa0c7bf | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 070791 ANDA070791 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Safecor Health, LLC | a2297f75-c498-419b-aa29-057271313a7f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 070791 ANDA070791 48433-035-20 48433-035 48433003520 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1ede17e6-19e9-455c-ad16-8029a590735c | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 070791 ANDA070791 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d2a91b99-513d-4894-ad6d-02d2028a2290 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 070791 ANDA070791 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 1533343b-f1ed-4c3a-bb36-23a748452b05 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 070791 ANDA070791 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Mylan Institutional Inc. | 137a953b-3c48-405f-86a6-ff778cb7f5f2 | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | 070791 ANDA070791 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 10d9eba6-30d1-448a-8d92-a1a02df03303 | 2017-09-05 | Boxed warning, Warnings, Adverse reactions | 070791 ANDA070791 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxepin Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|---|
| a2297f75-c498-419b-aa29-057271313a7f | 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 |
|---|---|---|---|---|---|---|
| 48433-035-01 | Doxepin Hydrochloride | 1 in 1 BLISTER PACK | CAPSULE | 1 | 2 | |
| 48433-035-20 | Doxepin Hydrochloride | 100 in 1 CARTON | CAPSULE | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 48433-035-20 | EA - Each | 48433-035 | bb390555-e646-4799-aab0-0b8a132346fd | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 48433-035-20 | 48433003520 | 100 BLISTER PACK in 1 CARTON (48433-035-20) / 1 CAPSULE in 1 BLISTER PACK (48433-035-01) | 100 blister pack | 2026-02-23 | No | No | Current |