Baclofen

Product NDC: 16714-072
Requested package NDC: 16714-072-04
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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078401-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078401-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078401-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078401-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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

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 · 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 (package): 16714-072-04 ndc (product): 16714-072 ndc11 (package): 16714007204
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

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

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