Nortriptyline Hydrochloride

Product NDC: 70771-1614
Requested package NDC: 70771-1614-5
11-digit product format: 707711614
Labeler code: 70771
Product ID: 70771-1614_b4fba0cb-3323-416a-81e0-adfbc3a0633b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA213441
Marketing category: ANDA
Marketing start: 2022-02-10
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A213441-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24
A213441-002	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24
A213441-003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24
A213441-004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24

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 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213441-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213441-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213441-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213441-004	AB	1	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

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

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	50 mg/1

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
70771-1614-1	Nortriptyline Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	2
70771-1614-3	Nortriptyline Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	2
70771-1614-5	Nortriptyline Hydrochloride	500 in 1 BOTTLE	CAPSULE	500	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1614	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, Legacy NDC, 3 package rows	20241212_f22dce73-b895-4fe2-8cf7-816dca93c246.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	dbe85bdc-17a1-4201-bf48-a52e35d69b68	2024-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213441 application number: ANDA213441

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	f22dce73-b895-4fe2-8cf7-816dca93c246	2
317136	nortriptyline HCl 25 MG Oral Capsule	PSN	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198047	nortriptyline HCl 75 MG Oral Capsule	PSN	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198045	nortriptyline 10 MG Oral Capsule	SCD	f22dce73-b895-4fe2-8cf7-816dca93c246	2
317136	nortriptyline 25 MG Oral Capsule	SCD	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198046	nortriptyline 50 MG Oral Capsule	SCD	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198047	nortriptyline 75 MG Oral Capsule	SCD	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	f22dce73-b895-4fe2-8cf7-816dca93c246	2
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	f22dce73-b895-4fe2-8cf7-816dca93c246	2
198047	nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule	SY	f22dce73-b895-4fe2-8cf7-816dca93c246	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1614-5	70771161405	500 CAPSULE in 1 BOTTLE (70771-1614-5)	500 capsule	2022-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Capsules, USP Rx only	Zydus Lifesciences Limited	2026-11-03	HUMAN PRESCRIPTION DRUG LABEL	3