Baclofen

Product NDC: 25021-679
11-digit product format: 250210679
Labeler code: 25021
Product ID: 25021-679_9ae563da-240a-468d-bc42-ed4667df2392
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: INJECTION, SOLUTION
Route: INTRATHECAL
Labeler: Sagent Pharmaceuticals
Application: ANDA210048
Marketing category: ANDA
Marketing start: 2021-07-15
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: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210048-001	BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP		2019-09-11
A210048-002	BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP		2019-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210048-001	AP
A210048-002	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 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210048-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210048-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210048-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210048-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210048-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210048-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210048-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210048-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210048-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210048-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210048-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210048-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210048-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210048-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210048-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210048-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210048-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210048-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	2000 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308517	Internal RxNorm lookup
1666613	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
077aaf3b-1ca3-4599-a51a-6bbe39810ca8	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
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
25021-679-20	Baclofen	1 in 1 CARTON	INJECTION, SOLUTION	1		1
25021-679-20	Baclofen	20 mL in 1 VIAL	INJECTION, SOLUTION	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-679-20	ML - Milliliter	25021-679	473d1877-f8b6-4fb8-8a6b-a56d629bdbaa	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-679	BACLOFEN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	1	Current NDC, Legacy NDC, 2 package rows	20210715_077aaf3b-1ca3-4599-a51a-6bbe39810ca8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen (Intrathecal)	BACLOFEN	MAIA Pharmaceuticals, Inc.	11ba5575-a856-414a-89f8-17f3a01de55b	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210048 application number: ANDA210048
Baclofen	BACLOFEN	Sagent Pharmaceuticals	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	2021-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210048 application number: ANDA210048 ndc (product): 25021-679

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	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	1
1666613	baclofen 40 MG in 20 ML (2,000 MCG/ML) Injection	PSN	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	1
308517	20 ML baclofen 0.5 MG/ML Injection	SCD	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	1
1666613	20 ML baclofen 2 MG/ML Injection	SCD	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	1
308517	baclofen 10,000 MCG per 20 ML Injection	SY	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	1
1666613	baclofen 40,000 MCG per 20 ML Injection	SY	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-679-20	25021067920	1 VIAL in 1 CARTON (25021-679-20) / 20 mL in 1 VIAL	1 vial	2021-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Injection (Intrathecal), USP*	Sagent Pharmaceuticals	2021-06-24	HUMAN PRESCRIPTION DRUG LABEL	1