Application 213474

Type: ANDA
Sponsor: CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 25MG BASE	No	No
003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No
004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No
005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG BASE	No	No

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	Approval date
A213474-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28
A213474-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28
A213474-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28
A213474-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28
A213474-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213474-001	AB
A213474-002	AB
A213474-003	AB
A213474-004	AB
A213474-005	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.

Product history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 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	A213474-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213474-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213474-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213474-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213474-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213474-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213474-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213474-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213474-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213474-005	AB	1	`5bbf6a4d5a75…`

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.

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	PD-Rx Pharmaceuticals, Inc.	8f7e9677-cc84-414b-8eb8-33993d285bb3	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213474 application number: ANDA213474
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	eb6954cf-e96b-4e54-961d-6b094384bac9	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213474 application number: ANDA213474
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	ec948b3d-4853-41bb-9f01-faf28fe369e5	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213474 application number: ANDA213474 ndc (product): 71335-1941
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	6e22050f-95ee-410a-b770-0c32fb8b321b	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213474 application number: ANDA213474
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	a4c804e3-4706-48d8-b928-b22c2dcaeed8	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213474 application number: ANDA213474
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Florida Pharmaceutical Products, LLC	b787a283-f882-e1f0-e053-2a95a90a8975	2021-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213474 application number: ANDA213474 ndc (product): 71921-162 ndc (product): 71921-166 ndc (product): 71921-164 ndc (product): 71921-163 ndc (product): 71921-165
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Contract Pharmacal Corp.	abbf7078-a012-4e1a-e053-2995a90a792d	2020-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213474 application number: ANDA213474 ndc (product): 10267-5061 ndc (product): 10267-5060 ndc (product): 10267-5059 ndc (product): 10267-5063 ndc (product): 10267-5062

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10267-5059	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacal Corp.	ANDA	Current
10267-5060	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacal Corp.	ANDA	Current
10267-5061	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacal Corp.	ANDA	Current
10267-5062	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacal Corp.	ANDA	Current
10267-5063	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacal Corp.	ANDA	Current
70518-3310	Doxepin Hydrochloride	Doxepin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3314	Doxepin Hydrochloride	Doxepin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3327	Doxepin Hydrochloride	Doxepin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3360	Doxepin Hydrochloride	Doxepin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3374	Doxepin Hydrochloride	Doxepin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1941	Doxepin Hydrochloride	Doxepin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1941	Doxepin Hydrochloride	Doxepin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71921-162	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-162	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-162	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-163	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-163	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-163	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-164	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-164	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-164	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-165	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-165	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-165	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-166	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-166	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-166	Doxepin Hydrochloride	Doxepin Hydrochloride	Florida Pharmaceutical Products, LLC	ANDA	Current