Doxepin Hydrochloride

Product NDC: 51079-436
11-digit product format: 510790436
Labeler code: 51079
Product ID: 51079-436_3a3b3b4a-148f-1dc5-e063-6394a90a7bdb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxepin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA070791
Marketing category: ANDA
Marketing start: 1998-06-12
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A070791-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A070791-005	AB	1	`a50c72e98297…`

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.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Safecor Health, LLC	a2297f75-c498-419b-aa29-057271313a7f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1ede17e6-19e9-455c-ad16-8029a590735c	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d2a91b99-513d-4894-ad6d-02d2028a2290	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1533343b-f1ed-4c3a-bb36-23a748452b05	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Institutional Inc.	137a953b-3c48-405f-86a6-ff778cb7f5f2	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791 ndc (product): 51079-436
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	10d9eba6-30d1-448a-8d92-a1a02df03303	2017-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791

Additional Listing Data#

Finished product: Yes
Brand name base: Doxepin Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXEPIN HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3U9A0FE9N5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000048	Internal RxNorm lookup
1000058	Internal RxNorm lookup
1000070	Internal RxNorm lookup
1000076	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
137a953b-3c48-405f-86a6-ff778cb7f5f2	Available on FDA.report

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	Strength	SPL version
51079-436-01	Doxepin Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1		12
51079-436-20	Doxepin Hydrochloride	100 in 1 CARTON	CAPSULE	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-436-01	EA - Each	51079-436	afa45847-4da1-41c4-94e7-41488fb141f9	1	2012-07-24
51079-436-20	EA - Each	51079-436	f9388275-f168-4981-80ee-8340417ac371	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 [MYLAN INSTITUTIONAL INC.]	2
DOXEPIN	ACTIVE MOIETY	5ASJ6HUZ7D	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-436	DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	11	Current NDC, Legacy NDC, 2 package rows	20240920_137a953b-3c48-405f-86a6-ff778cb7f5f2.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
1000048	doxepin HCl 10 MG Oral Capsule	PSN	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000058	doxepin HCl 100 MG Oral Capsule	PSN	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000070	doxepin HCl 25 MG Oral Capsule	PSN	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000076	doxepin HCl 50 MG Oral Capsule	PSN	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000048	doxepin 10 MG Oral Capsule	SCD	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000058	doxepin 100 MG Oral Capsule	SCD	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000070	doxepin 25 MG Oral Capsule	SCD	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000076	doxepin 50 MG Oral Capsule	SCD	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000058	doxepin (as doxepin HCl) 100 MG Oral Capsule	SY	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000070	doxepin (as doxepin HCl) 25 MG Oral Capsule	SY	137a953b-3c48-405f-86a6-ff778cb7f5f2	12
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	137a953b-3c48-405f-86a6-ff778cb7f5f2	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-436-01	51079043601	1 in 1 BLISTER PACK						Historical
51079-436-20	51079043620	100 BLISTER PACK in 1 CARTON (51079-436-20) / 1 CAPSULE in 1 BLISTER PACK (51079-436-01)	100 blister pack	1998-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxepin Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	12