Nortriptyline Hydrochloride

Product NDC: 72888-157
11-digit product format: 728880157
Labeler code: 72888
Product ID: 72888-157_47ca5d0b-0a49-87d1-e063-6394a90a1edb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Advagen Pharma Ltd
Application: ANDA217731
Marketing category: ANDA
Marketing start: 2022-06-14
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 10 mg/5mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217731-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA		2023-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217731-001	AA

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217731-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2023-08-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217731-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217731-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217731-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217731-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217731-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217731-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217731-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217731-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217731-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217731-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217731-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217731-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217731-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217731-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217731-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217731-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217731-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217731-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217731-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217731-001	AA	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217731-001	AA	1	`a50c72e98297…`

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	10 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312036	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
bef9e24d-e730-4801-ab25-75e7d6bde225	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	Strength	SPL version
72888-157-39	Nortriptyline Hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-157	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [ADVAGEN PHARMA LTD]	1	Current NDC, 1 package rows	20230923_bef9e24d-e730-4801-ab25-75e7d6bde225.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	Advagen Pharma Ltd	bef9e24d-e730-4801-ab25-75e7d6bde225	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217731 application number: ANDA217731 ndc (product): 72888-157

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
312036	nortriptyline HCl 10 MG in 5 mL Oral Solution	PSN	bef9e24d-e730-4801-ab25-75e7d6bde225	2
312036	nortriptyline 2 MG/ML Oral Solution	SCD	bef9e24d-e730-4801-ab25-75e7d6bde225	2
312036	nortriptyline (as nortriptyline hydrochloride) 10 MG per 5 ML Oral Solution	SY	bef9e24d-e730-4801-ab25-75e7d6bde225	2
312036	nortriptyline HCl 10 MG per 5 ML Oral Solution	SY	bef9e24d-e730-4801-ab25-75e7d6bde225	2
312036	nortriptyline HCl 20 MG per 10 ML Oral Solution	SY	bef9e24d-e730-4801-ab25-75e7d6bde225	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72888-157-39	72888015739	473 mL in 1 BOTTLE (72888-157-39)	473 ml	2022-06-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Oral Solution, USP Rx Only	Advagen Pharma Ltd \| Rubicon Research Limited	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	2