Gablofen

Product NDC: 66794-151
Requested package NDC: 66794-151-01
11-digit product format: 667940151
Labeler code: 66794
Product ID: 66794-151_5135dfce-e3c4-a382-e063-6394a90a4875
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen Injection
Dosage form: INJECTION, SOLUTION
Route: INTRATHECAL
Labeler: Piramal Critical Care Inc
Application: NDA022462
Marketing category: NDA
Marketing start: 2017-04-01
Substance: BACLOFEN
Active strength: 50 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: 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 · 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.

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
2026-08-01 22:54:32	2026-06	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N022462-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022462-002	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022462-003	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022462-004	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 66794-151-01 ndc (product): 66794-151 ndc11 (package): 66794015101

Additional Listing Data#

Finished product: Yes
Brand name base: Gablofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	50 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H789N3FKE8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308517	Internal RxNorm lookup
1047437	Internal RxNorm lookup
1047440	Internal RxNorm lookup
1047444	Internal RxNorm lookup
1300890	Internal RxNorm lookup
1301627	Internal RxNorm lookup
1369783	Internal RxNorm lookup
1369784	Internal RxNorm lookup
1369787	Internal RxNorm lookup
1369788	Internal RxNorm lookup
1369791	Internal RxNorm lookup
1369792	Internal RxNorm lookup
1666613	Internal RxNorm lookup
1666615	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
00d3e846-dd92-448d-9ab8-6a07be823cc1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346	Product name	2	20251208
1b1393e5-f2d8-42f5-a070-e3416d619667	Product name	1	20250804
88583480-702d-4dfe-a31c-9c00abd818f8	Product name	7	20250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83d	Product name	2	20240703
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
6e532d1f-e0b5-46eb-a2be-d70bd338df9d	Product name	1	20220613
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ef6bc0bf-8134-f06b-70d9-4980df6f808e	Product name	5	20210615
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
eeec0918-7a2f-44bf-83d6-1216e507adbf	Product name	3	20191217
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
a5300adb-f538-4abb-a49e-f8f0b8d9ac75	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66794-151-01	Gablofen	1 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	1		43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66794-151-01	ML - Milliliter	66794-151	34e6b8ae-05d7-45c3-8217-6f927915fbfb	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66794-151	GABLOFEN (BACLOFEN INJECTION) INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]	40	Current NDC, Legacy NDC, 1 package rows	20250524_00d3e846-dd92-448d-9ab8-6a07be823cc1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H789N3FKE8	BACLOFEN	1134-47-0	BACLOFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308517	baclofen 10 MG in 20 ML (500 MCG/ML) Injection	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369783	baclofen 10,000 MCG in 20 ML (500 MCG/ML) Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1300890	baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369787	baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1666613	baclofen 40 MG in 20 ML (2,000 MCG/ML) Injection	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369791	baclofen 40,000 MCG in 20 ML (2,000 MCG/ML) Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047437	baclofen 50 MCG in 1 ML Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047444	Gablofen 10,000 MCG in 20 ML (500 MCG/ML) Injection	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369784	Gablofen 10,000 MCG in 20 ML (500 MCG/ML) Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1301627	Gablofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369788	Gablofen 20,000 MCG in 20 ML (1,000 MCG/ML) Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1666615	Gablofen 40,000 MCG in 20 ML (2,000 MCG/ML) Injection	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369792	Gablofen 40,000 MCG in 20 ML (2,000 MCG/ML) Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047440	Gablofen 50 MCG in 1 ML Prefilled Syringe	PSN	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047440	1 ML baclofen 0.05 MG/ML Prefilled Syringe [Gablofen]	SBD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047444	20 ML baclofen 0.5 MG/ML Injection [Gablofen]	SBD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369784	20 ML baclofen 0.5 MG/ML Prefilled Syringe [Gablofen]	SBD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1301627	20 ML baclofen 1 MG/ML Injection [Gablofen]	SBD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369788	20 ML baclofen 1 MG/ML Prefilled Syringe [Gablofen]	SBD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1666615	20 ML baclofen 2 MG/ML Injection [Gablofen]	SBD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369792	20 ML baclofen 2 MG/ML Prefilled Syringe [Gablofen]	SBD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047437	1 ML baclofen 0.05 MG/ML Prefilled Syringe	SCD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
308517	20 ML baclofen 0.5 MG/ML Injection	SCD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369783	20 ML baclofen 0.5 MG/ML Prefilled Syringe	SCD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1300890	20 ML baclofen 1 MG/ML Injection	SCD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369787	20 ML baclofen 1 MG/ML Prefilled Syringe	SCD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1666613	20 ML baclofen 2 MG/ML Injection	SCD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369791	20 ML baclofen 2 MG/ML Prefilled Syringe	SCD	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047440	1 ML Gablofen 0.05 MG/ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047444	20 ML Gablofen 0.5 MG/ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369784	20 ML Gablofen 0.5 MG/ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1301627	20 ML Gablofen 1 MG/ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369788	20 ML Gablofen 1 MG/ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1666615	20 ML Gablofen 2 MG/ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369792	20 ML Gablofen 2 MG/ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
308517	baclofen 10,000 MCG per 20 ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369783	baclofen 10,000 MCG per 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369791	baclofen 2 MG/ML 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1300890	baclofen 20,000 MCG per 20 ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369787	baclofen 20,000 MCG per 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1666613	baclofen 40,000 MCG per 20 ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369791	baclofen 40,000 MCG per 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047437	baclofen 50 MCG per 1 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047444	Gablofen 10,000 MCG per 20 ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369784	Gablofen 10,000 MCG per 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369792	Gablofen 2 MG/ML 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1301627	Gablofen 20,000 MCG per 20 ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369788	Gablofen 20,000 MCG per 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1666615	Gablofen 40,000 MCG per 20 ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1369792	Gablofen 40,000 mcg per 20 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047440	Gablofen 50 MCG per 1 ML Prefilled Syringe	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43
1047444	Gablofen 500 MCG per 1 ML Injection	SY	00d3e846-dd92-448d-9ab8-6a07be823cc1	43

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66794-151-01	66794015101	1 mL in 1 SYRINGE, GLASS (66794-151-01)	1 ml	2017-04-01	0000-00-00	No	No	Current