Baclofen

Product NDC: 70511-121
11-digit product format: 705110121
Labeler code: 70511
Product ID: 70511-121_58150ebf-c2d6-49be-a519-06d839637462
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: INJECTION
Route: INTRATHECAL
Labeler: MAlA Pharmaceuticals, Inc.
Application: ANDA210777
Marketing category: ANDA
Marketing start: 2021-04-02
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70511-121	70511-121-83	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210777-001	BACLOFEN	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP		2021-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210777-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210777-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2021-01-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210777-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210777-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210777-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210777-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210777-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210777-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210777-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210777-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210777-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210777-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210777-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210777-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210777-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210777-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210777-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210777-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210777-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210777-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210777-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210777-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210777-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210777-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210777-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210777-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210777-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210777-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210777-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210777-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210777-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210777-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210777-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210777-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210777-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210777-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210777-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1047437	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
e05080ef-53d9-4060-aaa4-86a6935467de	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
6e532d1f-e0b5-46eb-a2be-d70bd338df9d	Product name	1	20220613
ef6bc0bf-8134-f06b-70d9-4980df6f808e	Product name	5	20210615
eeec0918-7a2f-44bf-83d6-1216e507adbf	Product name	3	20191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75	Product name	1	20190611

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70511-121	BACLOFEN INJECTION [MALA PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC	20230525_e05080ef-53d9-4060-aaa4-86a6935467de.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	BACLOFEN	MAlA Pharmaceuticals, Inc.	e05080ef-53d9-4060-aaa4-86a6935467de	2023-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210777 application number: ANDA210777 ndc (product): 70511-121
Baclofen	BACLOFEN	Sagent Pharmaceuticals	ea32c39c-0ee3-4b5e-8da7-4c31db334bd8	2021-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210777 application number: ANDA210777

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
1047437	baclofen 50 MCG in 1 ML Prefilled Syringe	PSN	e05080ef-53d9-4060-aaa4-86a6935467de	3
1047437	1 ML baclofen 0.05 MG/ML Prefilled Syringe	SCD	e05080ef-53d9-4060-aaa4-86a6935467de	3
1047437	baclofen 50 MCG per 1 ML Prefilled Syringe	SY	e05080ef-53d9-4060-aaa4-86a6935467de	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70511-121-80	70511012180	2 SYRINGE, GLASS in 1 CARTON (70511-121-80) / 1 mL in 1 SYRINGE, GLASS		2022-06-01		No	No	Current
70511-121-83	70511012183	5 CARTON in 1 CARTON (70511-121-83) > 1 SYRINGE, GLASS in 1 CARTON (70511-121-06) > 1 mL in 1 SYRINGE, GLASS	5 carton	2021-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen - MAlA Pharmaceuticals, Inc. \| Gland Pharma Limited	MAlA Pharmaceuticals, Inc. \| Gland Pharma Limited	2023-03-14	HUMAN PRESCRIPTION DRUG LABEL	3