Doxepin Hydrochloride

Product NDC: 49884-222
11-digit product format: 498840222
Labeler code: 49884
Product ID: 49884-222_75a2a220-95ff-4c6a-aa58-15e3352b6e7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA071422
Marketing category: ANDA
Marketing start: 1987-11-09
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49884-222		D	Discontinued by firm	2026-08-17
excluded package	package	49884-222	49884-222-01	D	Discontinued by firm	2026-08-17
excluded package	package	49884-222	49884-222-03	D	Discontinued by firm	2026-08-17
excluded package	package	49884-222	49884-222-05	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A071422-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1987-11-09
A071422-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	1987-11-09
A071422-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	1987-11-09
A071422-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	1987-11-09
A071422-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	1987-11-09
A071422-006	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	1987-11-09

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.

Product history page 1 of 7 · 247 observed states.

Captured, Edition, Application-product table
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	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071422-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071422-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071422-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071422-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071422-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071422-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071422-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071422-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071422-006	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071422-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071422-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071422-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071422-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071422-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071422-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071422-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071422-004	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	SPL version
49884-222-01	Doxepin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	29
49884-222-03	Doxepin Hydrochloride	50 in 1 BOTTLE	CAPSULE	50	29
49884-222-05	Doxepin Hydrochloride	500 in 1 BOTTLE	CAPSULE	500	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-222-01	EA - Each	49884-222	dd54443a-ea8f-46b5-94c3-c193dcba1c9c	1	2012-07-24
49884-222-03	EA - Each	49884-222	f59c4119-b6c7-4ec8-b663-9af83ae837af	1	2012-07-24
49884-222-05	EA - Each	49884-222	26a93056-8a3b-4591-81f3-af14ba7610af	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXEPIN HYDROCHLORIDE	ACTIVE INGREDIENT	3U9A0FE9N5	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
DOXEPIN	ACTIVE MOIETY	5ASJ6HUZ7D	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]	17
Doxepin Hydrochloride	ACTIVE INGREDIENT	3U9A0FE9N5	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Doxepin	ACTIVE MOIETY	5ASJ6HUZ7D	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Fd&c Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Fd&c Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Fd&c Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Gelatin	INACTIVE INGREDIENT	2G86QN327L	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Shellac	INACTIVE INGREDIENT	46N107B71O	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [AVKARE, INC.]	6
DOXEPIN HYDROCHLORIDE	ACTIVE INGREDIENT	3U9A0FE9N5	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
DOXEPIN	ACTIVE MOIETY	5ASJ6HUZ7D	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
D&C ORANGE NO. 10	INACTIVE INGREDIENT	YUW2S48521	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
DOXEPIN HYDROCHLORIDE	ACTIVE INGREDIENT	3U9A0FE9N5	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
DOXEPIN	ACTIVE MOIETY	5ASJ6HUZ7D	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-222	DOXEPIN HYDROCHLORIDE CAPSULE [ENDO USA, INC.]	29	Current NDC, Legacy NDC, 3 package rows	20241215_71cff7cd-0410-4194-9cdd-af404a869edd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3U9A0FE9N5	DOXEPIN HYDROCHLORIDE	1229-29-4	DOXEPIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000064	doxepin HCl 150 MG Oral Capsule	PSN	71cff7cd-0410-4194-9cdd-af404a869edd	29
1000064	doxepin 150 MG Oral Capsule	SCD	71cff7cd-0410-4194-9cdd-af404a869edd	29
1000064	doxepin (as doxepin HCl) 150 MG Oral Capsule	SY	71cff7cd-0410-4194-9cdd-af404a869edd	29
1000064	doxepin HCl 150 MG Oral Capsule	PSN	0d981fbd-3605-417b-91d7-799b21c1a9e3	17
1000064	doxepin 150 MG Oral Capsule	SCD	0d981fbd-3605-417b-91d7-799b21c1a9e3	17
1000064	doxepin (as doxepin HCl) 150 MG Oral Capsule	SY	0d981fbd-3605-417b-91d7-799b21c1a9e3	17
1000048	doxepin HCl 10 MG Oral Capsule	PSN	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000058	doxepin HCl 100 MG Oral Capsule	PSN	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000064	doxepin HCl 150 MG Oral Capsule	PSN	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000070	doxepin HCl 25 MG Oral Capsule	PSN	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000076	doxepin HCl 50 MG Oral Capsule	PSN	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000097	doxepin HCl 75 MG Oral Capsule	PSN	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000048	doxepin 10 MG Oral Capsule	SCD	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000058	doxepin 100 MG Oral Capsule	SCD	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000064	doxepin 150 MG Oral Capsule	SCD	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000070	doxepin 25 MG Oral Capsule	SCD	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000076	doxepin 50 MG Oral Capsule	SCD	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000097	doxepin 75 MG Oral Capsule	SCD	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000058	doxepin (as doxepin HCl) 100 MG Oral Capsule	SY	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000064	doxepin (as doxepin HCl) 150 MG Oral Capsule	SY	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000070	doxepin (as doxepin HCl) 25 MG Oral Capsule	SY	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000097	doxepin (as doxepin HCl) 75 MG Oral Capsule	SY	ef113645-b1a0-4327-86a0-9b066f0dd141	3
1000064	doxepin HCl 150 MG Oral Capsule	PSN	9ad86cfb-e91d-4e25-8bbc-fae3891c76d8	1
1000064	doxepin 150 MG Oral Capsule	SCD	9ad86cfb-e91d-4e25-8bbc-fae3891c76d8	1
1000064	doxepin (as doxepin HCl) 150 MG Oral Capsule	SY	9ad86cfb-e91d-4e25-8bbc-fae3891c76d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-222-01	49884022201	100 CAPSULE in 1 BOTTLE (49884-222-01)	100 capsule	1987-11-09	0000-00-00	No	No	Current
49884-222-03	49884022203	50 CAPSULE in 1 BOTTLE (49884-222-03)	50 capsule	1987-11-09	0000-00-00	No	No	Current
49884-222-05	49884022205	500 CAPSULE in 1 BOTTLE (49884-222-05)	500 capsule	1987-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXEPIN HYDROCHLORIDE CAPSULES USP	REMEDYREPACK INC.	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL	18
DOXEPIN HYDROCHLORIDE CAPSULES USP	Endo USA, Inc. \| Par Formulations Private Limited	2024-11-06	HUMAN PRESCRIPTION DRUG LABEL	29
Doxepin Hydrochloride Capsules	Bryant Ranch Prepack	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	103
Doxepin Hydrochloride Capsules	Bryant Ranch Prepack	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	103
Doxepin Hydrochloride Capsules	Bryant Ranch Prepack	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	103
Doxepin HCI Capsules, USP	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	10
DOXEPIN HYDROCHLORIDE - STAT Rx USA LLC \| PSS World Management Inc.	STAT Rx USA LLC \| PSS World Management Inc.	2012-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
Doxepin Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-12-04	HUMAN PRESCRIPTION DRUG LABEL	3