Baclofen

Product NDC: 80425-0282
Requested package NDC: 80425-0282-2
11-digit product format: 804250282
Labeler code: 80425
Product ID: 80425-0282_26f8bbf8-7c53-4c19-e063-6394a90a5a4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA212378
Marketing category: ANDA
Marketing start: 2020-10-09
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: 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…`

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 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
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 ndc (package): 80425-0282-2 ndc (product): 80425-0282 ndc11 (package): 80425028202
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

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f5edb656-4f7e-2386-e053-2995a90a70de	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	SPL version
80425-0282-1	Baclofen	30 in 1 BOTTLE	TABLET	30	2
80425-0282-2	Baclofen	60 in 1 BOTTLE	TABLET	60	2
80425-0282-3	Baclofen	90 in 1 BOTTLE	TABLET	90	2
80425-0282-4	Baclofen	120 in 1 BOTTLE	TABLET	120	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0282-1	EA - Each	80425-0282	6dc60c48-2657-425f-bc48-f4f288971577	1	2023-04-07
80425-0282-2	EA - Each	80425-0282	42f8d368-b537-40b6-9557-e8544b27c1ca	1	2023-04-07
80425-0282-3	EA - Each	80425-0282	b6333d87-6abb-4774-9644-0242ac576cf1	1	2023-04-07
80425-0282-4	EA - Each	80425-0282	f179f3fc-b772-4532-8048-9a3dba92b73c	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0282	BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 4 package rows	20241116_f5edb656-4f7e-2386-e053-2995a90a70de.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
197392	baclofen 20 MG Oral Tablet	PSN	f5edb656-4f7e-2386-e053-2995a90a70de	2
197392	baclofen 20 MG Oral Tablet	SCD	f5edb656-4f7e-2386-e053-2995a90a70de	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0282-2	80425028202	60 TABLET in 1 BOTTLE (80425-0282-2)	60 tablet	2020-10-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen 20mg Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-11-15	HUMAN PRESCRIPTION DRUG LABEL	2