Nortriptyline Hydrochloride

Product NDC: 70771-1613
11-digit product format: 707711613
Labeler code: 70771
Product ID: 70771-1613_b2965133-3b71-4cdb-8676-235882e57beb
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: 25 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	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 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`5d02ea3f76ae…`

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…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Zydus Lifesciences Limited	f22dce73-b895-4fe2-8cf7-816dca93c246	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213441 application number: ANDA213441 ndc (product): 70771-1613
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORTRIPTYLINE HYDROCHLORIDE	25 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
f22dce73-b895-4fe2-8cf7-816dca93c246	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
70771-1613-1	Nortriptyline Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	2
70771-1613-3	Nortriptyline Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	2
70771-1613-5	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
70771-1613	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, Legacy NDC, 3 package rows	20241212_f22dce73-b895-4fe2-8cf7-816dca93c246.zip

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
70771-1613-1	70771161301	100 CAPSULE in 1 BOTTLE (70771-1613-1)	100 capsule	2022-02-10	0000-00-00	No	No	Current
70771-1613-3	70771161303	30 CAPSULE in 1 BOTTLE (70771-1613-3)	30 capsule	2022-02-10	0000-00-00	No	No	Current
70771-1613-5	70771161305	500 CAPSULE in 1 BOTTLE (70771-1613-5)	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	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	2