Doxepin Hydrochloride

Product NDC: 71921-164
11-digit product format: 719210164
Labeler code: 71921
Product ID: 71921-164_ccbb860e-6367-5114-e053-2a95a90abfb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Florida Pharmaceutical Products, LLC
Application: ANDA213474
Marketing category: ANDA
Marketing start: 2021-05-01
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 50 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	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
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): 71921-164
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

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	50 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 · 5 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
1000097	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
b787a283-f882-e1f0-e053-2a95a90a8975	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
71921-164-01	Doxepin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71921-164-01	EA - Each	71921-164	ab46c96d-3990-49be-a435-111df1f3e606	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71921-164	DOXEPIN HYDROCHLORIDE CAPSULE [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20210925_b787a283-f882-e1f0-e053-2a95a90a8975.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	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000058	doxepin HCl 100 MG Oral Capsule	PSN	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000070	doxepin HCl 25 MG Oral Capsule	PSN	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000076	doxepin HCl 50 MG Oral Capsule	PSN	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000097	doxepin HCl 75 MG Oral Capsule	PSN	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000048	doxepin 10 MG Oral Capsule	SCD	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000058	doxepin 100 MG Oral Capsule	SCD	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000070	doxepin 25 MG Oral Capsule	SCD	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000076	doxepin 50 MG Oral Capsule	SCD	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000097	doxepin 75 MG Oral Capsule	SCD	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000058	doxepin (as doxepin HCl) 100 MG Oral Capsule	SY	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000070	doxepin (as doxepin HCl) 25 MG Oral Capsule	SY	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000097	doxepin (as doxepin HCl) 75 MG Oral Capsule	SY	8f7e9677-cc84-414b-8eb8-33993d285bb3	10
1000048	doxepin HCl 10 MG Oral Capsule	PSN	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000058	doxepin HCl 100 MG Oral Capsule	PSN	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000070	doxepin HCl 25 MG Oral Capsule	PSN	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000076	doxepin HCl 50 MG Oral Capsule	PSN	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000097	doxepin HCl 75 MG Oral Capsule	PSN	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000048	doxepin 10 MG Oral Capsule	SCD	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000058	doxepin 100 MG Oral Capsule	SCD	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000070	doxepin 25 MG Oral Capsule	SCD	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000076	doxepin 50 MG Oral Capsule	SCD	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000097	doxepin 75 MG Oral Capsule	SCD	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000058	doxepin (as doxepin HCl) 100 MG Oral Capsule	SY	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000070	doxepin (as doxepin HCl) 25 MG Oral Capsule	SY	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000097	doxepin (as doxepin HCl) 75 MG Oral Capsule	SY	b787a283-f882-e1f0-e053-2a95a90a8975	3
1000076	doxepin HCl 50 MG Oral Capsule	PSN	eb6954cf-e96b-4e54-961d-6b094384bac9	1
1000076	doxepin 50 MG Oral Capsule	SCD	eb6954cf-e96b-4e54-961d-6b094384bac9	1
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	eb6954cf-e96b-4e54-961d-6b094384bac9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71921-164-01	71921016401	100 CAPSULE in 1 BOTTLE (71921-164-01)	100 capsule	2021-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg	PD-Rx Pharmaceuticals, Inc.	2025-11-12	HUMAN PRESCRIPTION DRUG LABEL	10
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg	Bryant Ranch Prepack	2024-09-18	HUMAN PRESCRIPTION DRUG LABEL	1
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg	REMEDYREPACK INC.	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	3
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg	Florida Pharmaceutical Products, LLC \| Contract Pharmacal Corp.	2021-09-24	HUMAN PRESCRIPTION DRUG LABEL	3