BACLOFEN

Product NDC: 84386-035
11-digit product format: 843860035
Labeler code: 84386
Product ID: 84386-035_f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA214099
Marketing category: ANDA
Marketing start: 2025-11-21
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	84386-035		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	84386-035	84386-035-93	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

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
A214099-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13
A214099-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13
A214099-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2025-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214099-001	AB
A214099-002	AB
A214099-003	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 2 · 47 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
2024-08-13 05:28 UTC	2024-08	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC	2024-08	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC	2024-08	A214099-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC	2024-08	A214099-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214099-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214099-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214099-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214099-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214099-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214099-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214099-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214099-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214099-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214099-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214099-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214099-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214099-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214099-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214099-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214099-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214099-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214099-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214099-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214099-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214099-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214099-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214099-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214099-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214099-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214099-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214099-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214099-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214099-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214099-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214099-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214099-002	AB	1	`f41ea6bd6efb…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	355266e4-68f7-47d7-9f4e-1a0fc912786d	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Medcore LLC	13eca70c-3cc8-4317-83cf-ade3327e48c0	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	9bd46eb6-53b2-4845-88b4-81c1ced08aaa	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	3fdfeef9-68b3-4f6c-a4de-28179758a962	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Aurobindo Pharma Limited	f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099 ndc (product): 84386-035
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	844a09ab-6c11-44fa-a09b-09e2b7a3759e	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	HAWAII REPACK, INC.	bc48a775-1feb-44c4-9453-e1ccf3d929bd	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Aurobindo Pharma Limited	4679a275-9307-4b0f-a2eb-2d83227ea84d	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	NuCare Pharmaceuticals,Inc.	fd00fa8f-2797-c3f0-e053-6294a90a975f	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	687f48da-bc41-4700-9513-77a32fc86c93	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a58145a-57f9-6bb1-e063-6294a90a32a8	2024-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a586399-49e9-1e5c-e063-6294a90a4872	2024-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Quality Care Products, LLC	67df80a6-7fff-496e-9a89-d43a06c2a11f	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a	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
84386-035-01	BACLOFEN	100 in 1 BOTTLE	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
84386-035-01	EA - Each	84386-035	e757d4c7-e2f1-4f94-8346-ec5f10c00069	1	2026-04-20

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	f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a	1
430902	baclofen 5 MG Oral Tablet	SCD	f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84386-035-01	84386003501	100 TABLET in 1 BOTTLE (84386-035-01)	100 tablet	2025-11-21	No	No	Current
84386-035-93	84386003593	9000 TABLET in 1 BAG (84386-035-93)	9000 tablet	21-NOV-25			Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets USP Rx only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-11-24	Human Prescription Drug Label	1