Application 074132

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 25MG BASE	No	No
003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No
004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074132-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27
A074132-002	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27
A074132-003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27
A074132-004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074132-001	AB
A074132-002	AB
A074132-003	AB
A074132-004	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	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`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	A074132-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-004	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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	522d0cd8-d84d-4961-a525-4527fce44c3c	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	a2cf7783-7019-49ea-ab55-796674d94546	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	8eef261f-5c78-a88f-37c4-46e6b0e0f0ee	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	4c21abdb-f3e9-9037-e063-6294a90af4b4	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	Direct Rx	017f7717-e160-4142-9a5a-1a2bd9776707	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (product): 61919-171 ndc (product): 61919-435
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	American Health Packaging	d111c36d-98ed-4f0d-97ea-86fe9048deee	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	686d15d0-6434-42ec-8c78-f45d617d294c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	962f3f54-0556-4509-a231-ca62cb01bec8	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (product): 71335-0065
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	43a81887-42b8-43b5-b58a-3f3df2e9949b	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (product): 63629-3204
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (product): 0093-0811 ndc (product): 0093-0810 ndc (product): 0093-0813 ndc (product): 0093-0812
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	af950b46-07df-4de6-a221-d3d7059b87a1	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	e047f990-c374-4f8f-8583-c615f92545e2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (product): 71205-254
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	2f9fc7a0-163a-4a05-84a7-7999a41ecb1f	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (product): 63187-809
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	b387ba49-fd3f-4488-86e8-9b81e85ab232	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (product): 63187-759
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	f1868790-c70b-4979-974d-3ce0ffe99e36	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	30263e15-de21-4db4-aceb-59d619909e82	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0810	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0810	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0810	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0810	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0810	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0811	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0811	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0811	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0811	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0811	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0812	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0812	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0812	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0812	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0812	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0813	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0813	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0813	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0813	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0813	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
33261-348	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-692	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-804	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
49999-215	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50436-0810	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Unit Dose Services	ANDA	Current
61919-171	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	Direct Rx	ANDA	Current
61919-238	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-435	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	Direct Rx	ANDA	Current
63187-759	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63187-759	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63187-759	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63187-759	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63187-809	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63187-809	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63187-809	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63187-809	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
63629-3204	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-3204	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-3204	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
66336-973	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
67544-078	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-078	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68151-2898	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Carilion Materials Management	ANDA	Current
68788-9749	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9879	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9880	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-254	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
71205-254	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
71205-254	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
71205-254	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0065	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0065	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current