Doxepin

Product NDC: 72819-162
11-digit product format: 728190162
Labeler code: 72819
Product ID: 72819-162_0e1f91fa-a035-857e-e063-6394a90a68c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Archis Pharma LLC
Application: ANDA202337
Marketing category: ANDA
Marketing start: 2021-08-01
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 6 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXEPIN HYDROCHLORIDE	6 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	3U9A0FE9N5
Rxcui	966787, 966793

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
72819-162-03	Doxepin	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
72819-162-10	Doxepin	100 in 1 BOTTLE	TABLET, FILM COATED	100		3
72819-162-11	Doxepin	500 in 1 BOTTLE	TABLET, FILM COATED	500		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72819-162-03	EA - Each	72819-162	e80f260d-13d3-469b-b554-ec46406aee45	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72819-162	DOXEPIN TABLET, FILM COATED [ARCHIS PHARMA LLC]	3	Current NDC, Legacy NDC, 3 package rows	20240105_e3eac8e4-224e-4b7b-81d3-071301f914fa.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3U9A0FE9N5	DOXEPIN HYDROCHLORIDE	1229-29-4	DOXEPIN HYDROCHLORIDE
5ASJ6HUZ7D	DOXEPIN	1668-19-5	Doxepin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966787	doxepin 3 MG Oral Tablet	PSN	e3eac8e4-224e-4b7b-81d3-071301f914fa	3
966793	doxepin 6 MG Oral Tablet	PSN	e3eac8e4-224e-4b7b-81d3-071301f914fa	3
966787	doxepin 3 MG Oral Tablet	SCD	e3eac8e4-224e-4b7b-81d3-071301f914fa	3
966793	doxepin 6 MG Oral Tablet	SCD	e3eac8e4-224e-4b7b-81d3-071301f914fa	3
966787	doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral Tablet	SY	e3eac8e4-224e-4b7b-81d3-071301f914fa	3
966793	doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral Tablet	SY	e3eac8e4-224e-4b7b-81d3-071301f914fa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72819-162-03	72819016203	30 TABLET, FILM COATED in 1 BOTTLE (72819-162-03)	2022-02-21	0000-00-00	No	No	Current
72819-162-10	72819016210	100 TABLET, FILM COATED in 1 BOTTLE (72819-162-10)	2022-02-21	0000-00-00	No	No	Current
72819-162-11	72819016211	500 TABLET, FILM COATED in 1 BOTTLE (72819-162-11)	2022-02-21	0000-00-00	No	No	Current