Baclofen

Product NDC: 0172-4096
11-digit product format: 001724096
Labeler code: 0172
Product ID: 0172-4096_ba227be6-e946-423c-a9a6-e0626d889ea7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA072234
Marketing category: ANDA
Marketing start: 1988-07-21
Substance: BACLOFEN
Active strength: 10 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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072234-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		1988-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072234-001	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 2 · 41 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	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A072234-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072234-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072234-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072234-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072234-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072234-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072234-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072234-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072234-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072234-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072234-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072234-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072234-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072234-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072234-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072234-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072234-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072234-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072234-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072234-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072234-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072234-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072234-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072234-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072234-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072234-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072234-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072234-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072234-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072234-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072234-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072234-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072234-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072234-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072234-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072234-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072234-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072234-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072234-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072234-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	10 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
5648c772-50cb-4961-996e-e68a8eb699ea	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
0172-4096-60	Baclofen	100 in 1 BOTTLE	TABLET	100		19
0172-4096-80	Baclofen	1000 in 1 BOTTLE	TABLET	1000		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0172-4096-60	EA - Each	0172-4096	fc4535a2-1562-4831-85d4-1cd115b2f587	1	2012-07-24
0172-4096-80	EA - Each	0172-4096	ee681073-3bde-4c88-ab28-e469030c56c1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	12
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PROFICIENT RX LP]	3
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PROFICIENT RX LP]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [PROFICIENT RX LP]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [PROFICIENT RX LP]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [PROFICIENT RX LP]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [DIRECT RX]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0172-4096	BACLOFEN TABLET [TEVA PHARMACEUTICALS USA, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20210518_5648c772-50cb-4961-996e-e68a8eb699ea.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Northwind Health Company, LLC	06bcfb08-2ada-f803-e063-6394a90a826b	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	95755a7b-4a9f-45ea-a381-d3f661150efe	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c4164-e607-2e27-e053-2a95a90ad7db	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	Proficient Rx LP	b981eb16-a195-41da-a186-3e91b63b2def	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	Teva Pharmaceuticals USA, Inc.	5648c772-50cb-4961-996e-e68a8eb699ea	2019-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (product): 0172-4096

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	95755a7b-4a9f-45ea-a381-d3f661150efe	27
197391	baclofen 10 MG Oral Tablet	SCD	95755a7b-4a9f-45ea-a381-d3f661150efe	27
197391	baclofen 10 MG Oral Tablet	PSN	5648c772-50cb-4961-996e-e68a8eb699ea	19
197392	baclofen 20 MG Oral Tablet	PSN	5648c772-50cb-4961-996e-e68a8eb699ea	19
197391	baclofen 10 MG Oral Tablet	SCD	5648c772-50cb-4961-996e-e68a8eb699ea	19
197392	baclofen 20 MG Oral Tablet	SCD	5648c772-50cb-4961-996e-e68a8eb699ea	19
197391	baclofen 10 MG Oral Tablet	PSN	36f8b9c9-4e9d-41e4-b889-05cb948c6718	10
197391	baclofen 10 MG Oral Tablet	SCD	36f8b9c9-4e9d-41e4-b889-05cb948c6718	10
197391	baclofen 10 MG Oral Tablet	PSN	b33c4164-e607-2e27-e053-2a95a90ad7db	7
197391	baclofen 10 MG Oral Tablet	PSN	b981eb16-a195-41da-a186-3e91b63b2def	7
197391	baclofen 10 MG Oral Tablet	SCD	b981eb16-a195-41da-a186-3e91b63b2def	7
197391	baclofen 10 MG Oral Tablet	SCD	b33c4164-e607-2e27-e053-2a95a90ad7db	7
197391	baclofen 10 MG Oral Tablet	PSN	ec9c8b7f-9fb0-4274-9532-2fee335c055d	6
197391	baclofen 10 MG Oral Tablet	SCD	ec9c8b7f-9fb0-4274-9532-2fee335c055d	6
197391	baclofen 10 MG Oral Tablet	PSN	19ec8066-f0e7-4f80-b596-abe7b1ad92cb	5
197391	baclofen 10 MG Oral Tablet	SCD	19ec8066-f0e7-4f80-b596-abe7b1ad92cb	5
197391	baclofen 10 MG Oral Tablet	PSN	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	PSN	06bcfb08-2ada-f803-e063-6394a90a826b	4
197392	baclofen 20 MG Oral Tablet	PSN	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	SCD	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	SCD	06bcfb08-2ada-f803-e063-6394a90a826b	4
197392	baclofen 20 MG Oral Tablet	SCD	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	PSN	962601f8-7567-4afe-90a0-6df356f5a297	2
197392	baclofen 20 MG Oral Tablet	PSN	962601f8-7567-4afe-90a0-6df356f5a297	2
197391	baclofen 10 MG Oral Tablet	SCD	962601f8-7567-4afe-90a0-6df356f5a297	2
197392	baclofen 20 MG Oral Tablet	SCD	962601f8-7567-4afe-90a0-6df356f5a297	2
197391	baclofen 10 MG Oral Tablet	PSN	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1
197392	baclofen 20 MG Oral Tablet	PSN	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1
197391	baclofen 10 MG Oral Tablet	SCD	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1
197392	baclofen 20 MG Oral Tablet	SCD	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0172-4096-60	00172409660	100 TABLET in 1 BOTTLE (0172-4096-60)	100 tablet	1988-07-21	0000-00-00	No	No	Current
0172-4096-80	00172409680	1000 TABLET in 1 BOTTLE (0172-4096-80)	1000 tablet	1988-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets USP Rx only	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	4
Baclofen Tablets USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	27
Baclofen Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
BACLOFEN TABLETS USP	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	7
BACLOFEN	Direct_Rx \| Direct Rx	2023-02-03	HUMAN PRESCRIPTION DRUG LABEL	5
Baclofen Tablets USP Rx only	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	10
BACLOFEN TABLETS USP 4096 4097 Rx only	Unit Dose Services	2021-03-24	HUMAN PRESCRIPTION DRUG LABEL	6
Baclofen Tablets USP Rx only	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3
Baclofen Tablets USP Rx only	REMEDYREPACK INC.	2020-05-27	HUMAN PRESCRIPTION DRUG LABEL	5
BACLOFEN TABLETS USP 4096 4097 Rx only	REMEDYREPACK INC.	2020-04-07	HUMAN PRESCRIPTION DRUG LABEL	4
Baclofen Tablets USP Rx only	Teva Pharmaceuticals USA, Inc.	2019-12-31	HUMAN PRESCRIPTION DRUG LABEL	19
BACLOFEN TABLETS USP 4096 4097 Rx only	Preferred Pharmaceuticals, Inc.	2019-06-12	HUMAN PRESCRIPTION DRUG LABEL	7
BACLOFEN TABLETS, USP	Major Pharmaceuticals	2018-03-16	HUMAN PRESCRIPTION DRUG LABEL	13
BACLOFEN TABLETS USP	NCS HealthCare of KY, LLC dba Vangard Labs	2015-09-04	HUMAN PRESCRIPTION DRUG LABEL	8
BACLOFEN TABLETS USP	Physicians Total Care, Inc.	2014-02-13	HUMAN PRESCRIPTION DRUG LABEL	4
BACLOFEN TABLETS USP	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1
BACLOFEN TABLETS USP	H.J. Harkins Company, Inc. \| IVAX Pharmaceuticals, Inc.	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	2