Nortriptyline Hydrochloride

Product NDC: 51672-4004
Requested package NDC: 51672-4004-5
11-digit product format: 516724004
Labeler code: 51672
Product ID: 51672-4004_7ff22c22-51b5-4ce3-93ee-8959359fab3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA075520
Marketing category: ANDA
Marketing start: 2000-05-08
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 75 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075520-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08
A075520-002	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08
A075520-003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08
A075520-004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075520-001	AB
A075520-002	AB
A075520-003	AB
A075520-004	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.

Product history page 1 of 5 · 164 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	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075520-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075520-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075520-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075520-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2000-05-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A075520-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075520-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075520-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075520-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075520-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075520-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075520-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075520-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075520-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075520-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075520-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075520-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075520-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075520-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075520-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075520-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075520-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075520-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075520-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nortriptyline Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORTRIPTYLINE HYDROCHLORIDE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
00FN6IH15D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198045	Internal RxNorm lookup
198046	Internal RxNorm lookup
198047	Internal RxNorm lookup
317136	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
aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
de76de11-1019-6138-2d8a-16fa566ae22a	Product name	2	20241009
53e88688-54e1-9681-22b8-e499bd715088	Product name	2	20210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-4004-1	Nortriptyline Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	10
51672-4004-2	Nortriptyline Hydrochloride	500 in 1 BOTTLE	CAPSULE	500	10
51672-4004-5	Nortriptyline Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	10
51672-4004-6	Nortriptyline Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4004-1	EA - Each	51672-4004	35e9c47b-d08c-4ab8-b1cf-69da7225ecd4	1	2016-02-04
51672-4004-2	EA - Each	51672-4004	9adc480b-4a07-4b4e-a1a1-6dd34b3f7372	1	2015-05-05
51672-4004-5	EA - Each	51672-4004	3f1c96c5-552a-43ec-9d69-e74547b96d8c	1	2013-02-13
51672-4004-6	EA - Each	51672-4004	37162d6f-2274-453e-862a-dd0996a2a0df	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nortriptyline Hydrochloride	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
Nortriptyline	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
D&C Yellow NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
FD&C Blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
FD&C Blue NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
FD&C Green NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
FD&C Red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
gelatin	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
shellac	INACTIVE INGREDIENT	46N107B71O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4004	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	10	Current NDC, Legacy NDC, 4 package rows	20200508_aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28.zip

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520 ndc (package): 51672-4004-5 ndc (product): 51672-4004 ndc11 (package): 51672400405
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	dae3314f-3128-787f-e053-2995a90aff19	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	09a54dbd-6bde-3083-e063-6394a90a5297	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	51778813-0ec1-6b4f-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	53346b9c-40a1-4b5b-8df0-0b393661fb85	2024-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	DIRECT RX	45884cad-4a2d-44f4-93bd-16b130daf32d	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	cb4d1a69-60ae-4fdc-8af8-059959cf7265	2023-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	70921f99-1f25-4a8c-8269-6d5d26be7a63	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	59a65e6f-b812-4195-b85b-c412fb902c93	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	c5b1ef5e-9681-426a-abf6-60d9c28d92a0	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075520 application number: ANDA075520

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE	894-71-3	NORTRIPTYLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198045	nortriptyline HCl 10 MG Oral Capsule	PSN	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
317136	nortriptyline HCl 25 MG Oral Capsule	PSN	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198047	nortriptyline HCl 75 MG Oral Capsule	PSN	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198045	nortriptyline 10 MG Oral Capsule	SCD	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
317136	nortriptyline 25 MG Oral Capsule	SCD	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198046	nortriptyline 50 MG Oral Capsule	SCD	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198047	nortriptyline 75 MG Oral Capsule	SCD	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198047	nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule	SY	cb4d1a69-60ae-4fdc-8af8-059959cf7265	16
198045	nortriptyline HCl 10 MG Oral Capsule	PSN	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
317136	nortriptyline HCl 25 MG Oral Capsule	PSN	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198047	nortriptyline HCl 75 MG Oral Capsule	PSN	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198045	nortriptyline 10 MG Oral Capsule	SCD	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
317136	nortriptyline 25 MG Oral Capsule	SCD	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198046	nortriptyline 50 MG Oral Capsule	SCD	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198047	nortriptyline 75 MG Oral Capsule	SCD	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10
198047	nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule	SY	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4004-5	51672400405	90 CAPSULE in 1 BOTTLE (51672-4004-5)	90 capsule	2000-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Capsules, USP	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries, Ltd.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	11
Nortriptyline Hydrochloride Capsules, USP	REMEDYREPACK INC.	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	9
Nortriptyline Hydrochloride Capsules, USP	Bryant Ranch Prepack	2023-10-24	HUMAN PRESCRIPTION DRUG LABEL	16