Doxepin Hydrochloride

Product NDC: 21695-441
11-digit product format: 216950441
Labeler code: 21695
Product ID: 21695-441_f6ffd0d8-3451-425e-921e-faae1c1b8ad3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA070789
Marketing category: ANDA
Marketing start: 1986-05-13
Marketing end: 0000-00-00
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-441		I	Inactivated by FDA		2026-10-05
excluded package	package	21695-441	21695-441-30	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-441-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-441-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-441-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-441-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-441-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-441-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-441-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-441-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-441-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-441-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-441-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-441-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-441-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-441-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-441-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-441-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-441-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-441-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-441-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-441-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-441-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-441-30	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-441-30	2019-09-24	C162847	48780-1	934fe258-4a79-48b1-e053-8cdaa90a720a	DOXEPIN HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-441-30	Doxepin Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-441-30	EA - Each	21695-441	374a9e38-e18a-4e15-8193-95395d6ac3b9	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 [REBEL DISTRIBUTORS CORP]	2
Doxepin	ACTIVE MOIETY	5ASJ6HUZ7D	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-441	DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 1 package rows	20110517_24dd378e-0ef9-4ef8-8032-f81c1d87b3b8.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	24dd378e-0ef9-4ef8-8032-f81c1d87b3b8	2
1000076	doxepin HCl 50 MG Oral Capsule	PSN	24dd378e-0ef9-4ef8-8032-f81c1d87b3b8	2
1000048	doxepin 10 MG Oral Capsule	SCD	24dd378e-0ef9-4ef8-8032-f81c1d87b3b8	2
1000076	doxepin 50 MG Oral Capsule	SCD	24dd378e-0ef9-4ef8-8032-f81c1d87b3b8	2
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	24dd378e-0ef9-4ef8-8032-f81c1d87b3b8	2
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	24dd378e-0ef9-4ef8-8032-f81c1d87b3b8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-441-30	21695044130	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXEPIN HYDROCHLORIDE CAPSULES, USP	Rebel Distributors Corp	2010-12-20	HUMAN PRESCRIPTION DRUG LABEL	2