Application 018012

Type: NDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	SOLUTION;ORAL	EQ 10MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N018012-001	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION / ORAL		Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018012-001	PAMELOR	EQ 10MG BASE/5ML	SOLUTION / ORAL	Approved before 1982	`f41ea6bd6efb…`

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 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	4852a754-2fc1-4c10-a414-dc8a1dfd66a2	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c7cce83f-9508-49de-a442-246ad18ddeda	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	cb4d1a69-60ae-4fdc-8af8-059959cf7265	2026-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f684e9c8-eca7-4e27-872d-c0adea19de9a	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	3c57301f-5128-295e-e063-6394a90ad99e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	522d0cd8-d84d-4961-a525-4527fce44c3c	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	27e96d6c-b311-45d2-b879-65c6a4efcfba	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	21770082-7a99-520d-e063-6394a90ab9cb	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	a2cf7783-7019-49ea-ab55-796674d94546	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	8eef261f-5c78-a88f-37c4-46e6b0e0f0ee	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	4c21abdb-f3e9-9037-e063-6294a90af4b4	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3fcabf90-357a-4a06-b680-9572dc28bcfe	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	Direct Rx	017f7717-e160-4142-9a5a-1a2bd9776707	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Advagen Pharma Ltd	bef9e24d-e730-4801-ab25-75e7d6bde225	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	dae3314f-3128-787f-e053-2995a90aff19	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	09a54dbd-6bde-3083-e063-6394a90a5297	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	American Health Packaging	d111c36d-98ed-4f0d-97ea-86fe9048deee	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33391	SUPPL	2014-07-29
13976	SUPPL	2014-07-29
11112	SUPPL	2014-07-11
777	SUPPL	2014-07-11
776	SUPPL	2012-10-29
11111	SUPPL	2012-10-26
43603	ORIG	2009-11-20
40770	SUPPL	2009-09-14
775	SUPPL	2007-07-24
33390	SUPPL	2007-07-16
44016	ORIG	2007-05-09
11110	SUPPL	2005-01-13
774	SUPPL	2005-01-13
33389	SUPPL	2003-04-11