Gablofen

Product NDC: 45945-157
11-digit product format: 459450157
Labeler code: 45945
Product ID: 45945-157_5b051c22-c1c9-484c-969b-1c20e07e6c05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: INJECTION
Route: INTRATHECAL
Labeler: Mallinckrodt Inc (Brand Pharmaceuticals)
Application: NDA022462
Marketing category: NDA
Marketing start: 2010-11-19
Marketing end: 2020-01-31
Substance: BACLOFEN
Active strength: 2000 ug/mL
Pharmacologic classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45945-157		D	Discontinued by firm	2026-10-16
excluded package	package	45945-157	45945-157-01	D	Discontinued by firm	2026-10-16
excluded package	package	45945-157	45945-157-02	D	Discontinued by firm	2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45945-157-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45945-157-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45945-157-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45945-157-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45945-157-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45945-157-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45945-157-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45945-157-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45945-157-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45945-157-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45945-157-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45945-157-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45945-157-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45945-157-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45945-157-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45945-157-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45945-157-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45945-157-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45945-157-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45945-157-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45945-157-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45945-157-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45945-157-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45945-157-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	RLD / RS	Approval date
N022462-001	GABLOFEN	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19
N022462-002	GABLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19
N022462-003	GABLOFEN	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19
N022462-004	GABLOFEN	BACLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022462-001	AP
N022462-002	AP
N022462-003	AP
N022462-004	AP

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 5 · 176 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
2026-10-15 13:18:30	2026-09	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022462-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022462-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022462-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022462-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022462-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022462-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022462-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022462-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022462-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022462-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022462-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022462-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022462-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022462-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022462-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022462-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022462-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022462-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022462-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022462-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022462-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022462-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022462-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022462-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022462-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022462-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022462-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022462-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022462-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022462-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022462-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022462-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022462-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022462-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022462-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022462-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022462-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022462-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022462-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022462-004	AP	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45945-157-01	ML - Milliliter	45945-157	7f9ff189-5f93-4f1d-96c7-11ded56e033c	1	2013-04-01
45945-157-02	ML - Milliliter	45945-157	636618ee-12af-47bd-b98d-b88b9441ce7e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	GABLOFEN (BACLOFEN) INJECTION [MALLINCKRODT INC (BRAND PHARMACEUTICALS)]	23
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	GABLOFEN (BACLOFEN) INJECTION [MALLINCKRODT INC (BRAND PHARMACEUTICALS)]	23
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GABLOFEN (BACLOFEN) INJECTION [MALLINCKRODT INC (BRAND PHARMACEUTICALS)]	23
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABLOFEN (BACLOFEN) INJECTION [MALLINCKRODT INC (BRAND PHARMACEUTICALS)]	23

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
Gablofen	BACLOFEN INJECTION	Piramal Critical Care Inc	00d3e846-dd92-448d-9ab8-6a07be823cc1	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022462 application number: NDA022462