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 2 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	A-S Medication Solutions	686d15d0-6434-42ec-8c78-f45d617d294c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	962f3f54-0556-4509-a231-ca62cb01bec8	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	43a81887-42b8-43b5-b58a-3f3df2e9949b	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ba4edb34-82ac-4c98-8abd-fd6176838c78	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	6b055ebf-ed9e-44c5-bc03-6b6480d14377	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	60763e7a-d22c-47d5-a260-f64bd4a4f654	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	36b00c00-5fbd-c14b-e063-6294a90a49b7	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	2fffe23d-37f8-34fe-e063-6294a90a7b6c	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	2ccb3fd0-53c9-6015-e063-6294a90a3fd6	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Asclemed USA, Inc.	b02eb04a-83ee-45b0-b755-187fde2698c3	2025-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	2c92511f-0127-c74e-e063-6394a90a1214	2025-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Zydus Lifesciences Limited	f22dce73-b895-4fe2-8cf7-816dca93c246	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	SpecGx LLC	e17dc299-f52d-414d-ab6e-e809bd6f8acb	2024-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PAMELOR generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	e047f990-c374-4f8f-8583-c615f92545e2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	2f9fc7a0-163a-4a05-84a7-7999a41ecb1f	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	b387ba49-fd3f-4488-86e8-9b81e85ab232	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	661ec73c-d893-446a-83c3-218b06889962	2024-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	d72e5d1d-58f2-4d34-900a-54e5feb2f3eb	2024-08-22	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