Baclofen

Product NDC: 58657-730
11-digit product format: 586570730
Labeler code: 58657
Product ID: 58657-730_3aa113f3-27d5-328b-e063-6394a90af9e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Method Pharmaceuticals LLC
Application: ANDA212378
Marketing category: ANDA
Marketing start: 2024-06-15
Substance: BACLOFEN
Active strength: 5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212378-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09
A212378-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09
A212378-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212378-001	AB
A212378-002	AB
A212378-003	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 · 105 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	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A212378-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212378-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212378-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212378-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197391	Internal RxNorm lookup
197392	Internal RxNorm lookup
430902	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
1a9db542-d2b0-141a-e063-6394a90acc11	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
58657-730-01	Baclofen	100 in 1 BOTTLE	TABLET	100		2
58657-730-10	Baclofen	1000 in 1 BOTTLE	TABLET	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-730-01	EA - Each	58657-730	cf753041-f998-4825-bed3-ec2f170ce051	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-730	BACLOFEN TABLET [METHOD PHARMACEUTICALS LLC]	1	Current NDC, 2 package rows	20240617_1a9db542-d2b0-141a-e063-6394a90acc11.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	REMEDYREPACK INC.	6274e70a-fb57-461b-b1bc-39d4ff916b2a	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	REMEDYREPACK INC.	d689d32c-12a7-4ae4-afc3-8a353be67148	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	80b0a41e-2cad-4e14-9605-0cd35f9991e9	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	808113db-c5c2-404c-ab5f-62b991641cfe	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	0a5940cd-63eb-4d1b-8e92-44df264bc05a	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Method Pharmaceuticals LLC	1a9db542-d2b0-141a-e063-6394a90acc11	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 58657-730
Baclofen	BACLOFEN	Bryant Ranch Prepack	a748da19-d3eb-499e-986c-2043a1356f2b	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	3ac0f0d2-86d8-46d0-88e5-c243734b0814	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
BACLOFEN	BACLOFEN	XLCare Pharmaceuticals Inc.	2b4908fb-47b5-4675-be9e-ca1ad48a7252	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	c85a1884-f46f-5cd4-e053-2a95a90a3e27	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	ec09736a-dd2b-0a3b-e053-2995a90a9542	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	43cafbdb-6927-45f6-9b16-3b125cc2a29d	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	f5edb656-4f7e-2386-e053-2995a90a70de	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	08a6866f-b127-482f-9f22-113175487bdd	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	4634093b-6def-41d6-a7f3-23040125c4f4	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	655db2a3-daf7-4f4b-8f64-4a6d81fdc165	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	d24135b3-e247-412f-a10b-ceecbdee3aef	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	80a4c6f7-4f02-493c-9263-62e1c90404ba	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	ff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378

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
430902	baclofen 5 MG Oral Tablet	PSN	43cafbdb-6927-45f6-9b16-3b125cc2a29d	101
430902	baclofen 5 MG Oral Tablet	SCD	43cafbdb-6927-45f6-9b16-3b125cc2a29d	101
197391	baclofen 10 MG Oral Tablet	PSN	1a9db542-d2b0-141a-e063-6394a90acc11	2
197392	baclofen 20 MG Oral Tablet	PSN	1a9db542-d2b0-141a-e063-6394a90acc11	2
430902	baclofen 5 MG Oral Tablet	PSN	1a9db542-d2b0-141a-e063-6394a90acc11	2
197391	baclofen 10 MG Oral Tablet	SCD	1a9db542-d2b0-141a-e063-6394a90acc11	2
197392	baclofen 20 MG Oral Tablet	SCD	1a9db542-d2b0-141a-e063-6394a90acc11	2
430902	baclofen 5 MG Oral Tablet	SCD	1a9db542-d2b0-141a-e063-6394a90acc11	2
430902	baclofen 5 MG Oral Tablet	PSN	80b0a41e-2cad-4e14-9605-0cd35f9991e9	1
430902	baclofen 5 MG Oral Tablet	SCD	80b0a41e-2cad-4e14-9605-0cd35f9991e9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58657-730-01	58657073001	100 TABLET in 1 BOTTLE (58657-730-01)	100 tablet	2024-06-15	No	No	Current
58657-730-10	58657073010	1000 TABLET in 1 BOTTLE (58657-730-10)	1000 tablet	2024-06-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets, USP Rx only	Bryant Ranch Prepack	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	1
Baclofen Tablets, USP Rx only	Method Pharmaceuticals LLC	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	2
Baclofen Tablets, USP Rx only	Bryant Ranch Prepack	2024-11-27	HUMAN PRESCRIPTION DRUG LABEL	101