Nortriptyline Hydrochloride

Product NDC: 0121-0678
11-digit product format: 001210678
Labeler code: 0121
Product ID: 0121-0678_49445e55-d381-44c5-9e91-392f530d6dfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA075606
Marketing category: ANDA
Marketing start: 2000-08-23
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 1.

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
A075606-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075606-001	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.

Product history page 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL		RS	2000-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL		RS	2000-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL		RS	2000-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL		RS	2000-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075606-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	RS	2000-08-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075606-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075606-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075606-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075606-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075606-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075606-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075606-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075606-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075606-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075606-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075606-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075606-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075606-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075606-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075606-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075606-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075606-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075606-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075606-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075606-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075606-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075606-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075606-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075606-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075606-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075606-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075606-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075606-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075606-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075606-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075606-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075606-001	AA	1	`9b2671bbb829…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075606-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075606-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075606-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075606-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075606-001	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
3fcabf90-357a-4a06-b680-9572dc28bcfe	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
53e88688-54e1-9681-22b8-e499bd715088	Product name	2	20210729
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-0678-16	Nortriptyline Hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0678-16	ML - Milliliter	0121-0678	9d42db72-745b-4417-9156-98680332a6fc	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 SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
Nortriptyline	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0678	NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	14	Current NDC, Legacy NDC, 1 package rows	20241116_3fcabf90-357a-4a06-b680-9572dc28bcfe.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	PAI Holdings, LLC dba PAI Pharma	3fcabf90-357a-4a06-b680-9572dc28bcfe	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075606 application number: ANDA075606 ndc (product): 0121-0678

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	3fcabf90-357a-4a06-b680-9572dc28bcfe	15
312036	nortriptyline 2 MG/ML Oral Solution	SCD	3fcabf90-357a-4a06-b680-9572dc28bcfe	15
312036	nortriptyline (as nortriptyline hydrochloride) 10 MG per 5 ML Oral Solution	SY	3fcabf90-357a-4a06-b680-9572dc28bcfe	15
312036	nortriptyline HCl 10 MG per 5 ML Oral Solution	SY	3fcabf90-357a-4a06-b680-9572dc28bcfe	15
312036	nortriptyline HCl 20 MG per 10 ML Oral Solution	SY	3fcabf90-357a-4a06-b680-9572dc28bcfe	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0678-16	00121067816	473 mL in 1 BOTTLE (0121-0678-16)	473 ml	2000-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Oral Solution USP	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2026-01-26	HUMAN PRESCRIPTION DRUG LABEL	15