Baclofen

Product NDC: 16714-072
11-digit product format: 167140072
Labeler code: 16714
Product ID: 16714-072_a3881489-a033-4a93-ba24-590e316103f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Northstar RxLLC
Application: ANDA078401
Marketing category: ANDA
Marketing start: 2011-01-01
Substance: BACLOFEN
Active strength: 20 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078401-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB		2009-09-18
A078401-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		2009-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078401-001	AB
A078401-002	AB

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 3 · 82 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	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078401-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078401-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078401-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078401-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078401-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078401-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078401-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078401-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078401-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078401-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078401-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078401-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078401-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078401-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078401-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078401-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078401-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078401-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	A-S Medication Solutions	7ee42a29-21c2-47f8-a5b3-f3af115b665d	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401
Baclofen	BACLOFEN	Northstar RxLLC	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401 ndc (product): 16714-072
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c534d-4fa3-0a2f-e053-2995a90ab52f	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	9edc00c6-c281-4e81-b176-44b7536f71f2	2020-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	20 mg/1

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
197391	Internal RxNorm lookup
197392	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
0aac77fa-30c2-46c8-a04d-e6b8333ddd81	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-072-04	Baclofen	100 in 1 BOTTLE	TABLET	100		17
16714-072-05	Baclofen	500 in 1 BOTTLE	TABLET	500		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-072-04	EA - Each	16714-072	09473bc2-70ac-4c24-89ce-3e9509e790ce	1	2012-07-24
16714-072-05	EA - Each	16714-072	947731a4-8145-4d52-bd64-87513e66299a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [NORTHSTAR RXLLC]	11
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [NORTHSTAR RXLLC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [NORTHSTAR RXLLC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [NORTHSTAR RXLLC]	11
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	BACLOFEN TABLET [NORTHSTAR RXLLC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [NORTHSTAR RXLLC]	11
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	BACLOFEN TABLET [NORTHSTAR RXLLC]	11
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	4
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-072	BACLOFEN TABLET [NORTHSTAR RXLLC]	16	Current NDC, Legacy NDC, 2 package rows	20250409_0aac77fa-30c2-46c8-a04d-e6b8333ddd81.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
197391	baclofen 10 MG Oral Tablet	PSN	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	17
197392	baclofen 20 MG Oral Tablet	PSN	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	17
197391	baclofen 10 MG Oral Tablet	SCD	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	17
197392	baclofen 20 MG Oral Tablet	SCD	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	17
197392	baclofen 20 MG Oral Tablet	PSN	b33c534d-4fa3-0a2f-e053-2995a90ab52f	6
197392	baclofen 20 MG Oral Tablet	SCD	b33c534d-4fa3-0a2f-e053-2995a90ab52f	6
197392	baclofen 20 MG Oral Tablet	PSN	9edc00c6-c281-4e81-b176-44b7536f71f2	2
197392	baclofen 20 MG Oral Tablet	SCD	9edc00c6-c281-4e81-b176-44b7536f71f2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-072-04	16714007204	100 TABLET in 1 BOTTLE (16714-072-04)	100 tablet	2011-01-01	0000-00-00	No	No	Current
16714-072-05	16714007205	500 TABLET in 1 BOTTLE (16714-072-05)	500 tablet	2011-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only	Northstar RxLLC \| Piramal Pharma Limited	2025-11-05	Human Prescription Drug Label	17
Rx Only	Mckesson Corporation DBA SKY Packaginng	2025-04-10	HUMAN PRESCRIPTION DRUG LABEL	19
Baclofen Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2020-08-13	Human Prescription Drug Label	2