Baclofen

Product NDC: 71335-1664
11-digit product format: 713351664
Labeler code: 71335
Product ID: 71335-1664_7f9282e0-a178-48fe-99db-bc10ea061f6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA211555
Marketing category: ANDA
Marketing start: 2021-05-27
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 165 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1664-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1664-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1664-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1664-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1664-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1664-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1664-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1664-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1664-8	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211555-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2019-02-01
A211555-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2019-02-01
A211555-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211555-001	AB
A211555-002	AB
A211555-003	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 · 117 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
2026-08-18 06:07:40	2026-07	A211555-001	BACLOFEN	10MG	TABLET / ORAL	AB	2019-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211555-002	BACLOFEN	20MG	TABLET / ORAL	AB	2019-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211555-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-001	BACLOFEN	10MG	TABLET / ORAL	AB	2019-02-01	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211555-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211555-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211555-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211555-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-003	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-003	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211555-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211555-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-001	AB	1	`1e350fbaab3a…`

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 · 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
aeb56b0e-7126-4417-b726-e8a54f73de3f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
71335-1664-0	BACLOFEN TABLETS USP Rx only
71335-1664-0	BACLOFEN TABLETS USP Rx only
71335-1664-1	BACLOFEN TABLETS USP Rx only
71335-1664-1	BACLOFEN TABLETS USP Rx only
71335-1664-2	BACLOFEN TABLETS USP Rx only
71335-1664-2	BACLOFEN TABLETS USP Rx only
71335-1664-3	BACLOFEN TABLETS USP Rx only
71335-1664-3	BACLOFEN TABLETS USP Rx only
71335-1664-4	BACLOFEN TABLETS USP Rx only
71335-1664-4	BACLOFEN TABLETS USP Rx only
71335-1664-5	BACLOFEN TABLETS USP Rx only
71335-1664-5	BACLOFEN TABLETS USP Rx only
71335-1664-6	BACLOFEN TABLETS USP Rx only
71335-1664-6	BACLOFEN TABLETS USP Rx only
71335-1664-7	BACLOFEN TABLETS USP Rx only
71335-1664-7	BACLOFEN TABLETS USP Rx only
71335-1664-8	BACLOFEN TABLETS USP Rx only
71335-1664-8	BACLOFEN TABLETS USP Rx only
71335-1664-9	BACLOFEN TABLETS USP Rx only
71335-1664-9	BACLOFEN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1664-0	Baclofen	120 in 1 BOTTLE	TABLET	120	3
71335-1664-1	Baclofen	90 in 1 BOTTLE	TABLET	90	3
71335-1664-2	Baclofen	20 in 1 BOTTLE	TABLET	20	3
71335-1664-3	Baclofen	60 in 1 BOTTLE	TABLET	60	3
71335-1664-4	Baclofen	45 in 1 BOTTLE	TABLET	45	3
71335-1664-5	Baclofen	112 in 1 BOTTLE	TABLET	112	3
71335-1664-6	Baclofen	30 in 1 BOTTLE	TABLET	30	3
71335-1664-7	Baclofen	56 in 1 BOTTLE	TABLET	56	3
71335-1664-8	Baclofen	15 in 1 BOTTLE	TABLET	15	3
71335-1664-9	Baclofen	84 in 1 BOTTLE	TABLET	84	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1664	BACLOFEN TABLET [BRYANT RANCH PREPACK]	3	Legacy NDC, 10 package rows	20220521_aeb56b0e-7126-4417-b726-e8a54f73de3f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Bryant Ranch Prepack	aeb56b0e-7126-4417-b726-e8a54f73de3f	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211555 application number: ANDA211555 ndc (product): 71335-1664
Baclofen	BACLOFEN	Eywa Pharma Inc	7ec59f6b-7c4f-432d-ba27-442861806b6c	2026-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211555 application number: ANDA211555
Baclofen	BACLOFEN	NuCare Pharmaceuticals,Inc.	b2be2e6c-a247-30f4-e053-2a95a90a6ccb	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211555 application number: ANDA211555

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	aeb56b0e-7126-4417-b726-e8a54f73de3f	3
197392	baclofen 20 MG Oral Tablet	SCD	aeb56b0e-7126-4417-b726-e8a54f73de3f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1664-0	71335166400	120 TABLET in 1 BOTTLE (71335-1664-0)	120 tablet	2020-08-27	0000-00-00	No	No	Current
71335-1664-1	71335166401	90 TABLET in 1 BOTTLE (71335-1664-1)	90 tablet	2022-04-29	0000-00-00	No	No	Current
71335-1664-2	71335166402	20 TABLET in 1 BOTTLE (71335-1664-2)	20 tablet	2022-02-15	0000-00-00	No	No	Current
71335-1664-3	71335166403	60 TABLET in 1 BOTTLE (71335-1664-3)	60 tablet	2020-09-11	0000-00-00	No	No	Current
71335-1664-4	71335166404	45 TABLET in 1 BOTTLE (71335-1664-4)	45 tablet	2022-02-15	0000-00-00	No	No	Current
71335-1664-5	71335166405	112 TABLET in 1 BOTTLE (71335-1664-5)	112 tablet	2022-02-15	0000-00-00	No	No	Current
71335-1664-6	71335166406	30 TABLET in 1 BOTTLE (71335-1664-6)	30 tablet	2020-07-15	0000-00-00	No	No	Current
71335-1664-7	71335166407	56 TABLET in 1 BOTTLE (71335-1664-7)	56 tablet	2020-07-15	0000-00-00	No	No	Current
71335-1664-8	71335166408	15 TABLET in 1 BOTTLE (71335-1664-8)	15 tablet	2020-07-15	0000-00-00	No	No	Current
71335-1664-9	71335166409	84 TABLET in 1 BOTTLE (71335-1664-9)	84 tablet	2020-07-15	0000-00-00	No	No	Current