Baclofen

Product NDC: 71930-066
11-digit product format: 719300066
Labeler code: 71930
Product ID: 71930-066_7d9fb520-b11c-4e80-b2c8-1f642d5e78d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Eywa Pharma Inc
Application: ANDA211555
Marketing category: ANDA
Marketing start: 2021-05-27
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: 2027-12-31
Current FDA listing: Yes

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 1 · 60 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	71930-066-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71930-066-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71930-066-13	`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	71930-066-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71930-066-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71930-066-13	`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	71930-066-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71930-066-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71930-066-13	`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	71930-066-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71930-066-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71930-066-13	`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	71930-066-52	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71930-066-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71930-066-13	`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	71930-066-52	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71930-066-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71930-066-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71930-066-52	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71930-066-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71930-066-13	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71930-066-52	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71930-066-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71930-066-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71930-066-52	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71930-066-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71930-066-13	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71930-066-52	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71930-066-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71930-066-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71930-066-52	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71930-066-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71930-066-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71930-066-52	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71930-066-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71930-066-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71930-066-52	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71930-066-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71930-066-13	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71930-066-52	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71930-066-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71930-066-13	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71930-066-52	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71930-066-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71930-066-13	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 114 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-002	BACLOFEN	20MG	TABLET / ORAL	AB	2019-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211555-001	BACLOFEN	10MG	TABLET / ORAL	AB	2019-02-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211555-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2027-12-31

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
7ec59f6b-7c4f-432d-ba27-442861806b6c	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
eeec0918-7a2f-44bf-83d6-1216e507adbf	Product name	3	20191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75	Product name	1	20190611
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
71930-066-12	BACLOFEN TABLETS USP Rx only
71930-066-12	BACLOFEN TABLETS USP Rx only
71930-066-13	BACLOFEN TABLETS USP Rx only
71930-066-13	BACLOFEN TABLETS USP Rx only
71930-066-52	BACLOFEN TABLETS USP Rx only
71930-066-52	BACLOFEN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71930-066-12	Baclofen	100 in 1 BOTTLE	TABLET	100	6
71930-066-13	Baclofen	1000 in 1 BOTTLE	TABLET	1000	6
71930-066-52	Baclofen	500 in 1 BOTTLE	TABLET	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71930-066-12	EA - Each	71930-066	5ebe576e-919b-415e-be49-1ee84f758688	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71930-066	BACLOFEN TABLET [EYWA PHARMA INC]	5	Current NDC, Legacy NDC, 3 package rows	20220312_7ec59f6b-7c4f-432d-ba27-442861806b6c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 71930-066
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
197391	baclofen 10 MG Oral Tablet	PSN	7ec59f6b-7c4f-432d-ba27-442861806b6c	6
197392	baclofen 20 MG Oral Tablet	PSN	7ec59f6b-7c4f-432d-ba27-442861806b6c	6
430902	baclofen 5 MG Oral Tablet	PSN	7ec59f6b-7c4f-432d-ba27-442861806b6c	6
197391	baclofen 10 MG Oral Tablet	SCD	7ec59f6b-7c4f-432d-ba27-442861806b6c	6
197392	baclofen 20 MG Oral Tablet	SCD	7ec59f6b-7c4f-432d-ba27-442861806b6c	6
430902	baclofen 5 MG Oral Tablet	SCD	7ec59f6b-7c4f-432d-ba27-442861806b6c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71930-066-12	71930006612	100 TABLET in 1 BOTTLE (71930-066-12)	100 tablet	2021-05-27	0000-00-00	No	No	Current
71930-066-13	71930006613	1000 TABLET in 1 BOTTLE (71930-066-13)	1000 tablet	2021-05-27	0000-00-00	No	No	Current
71930-066-52	71930006652	500 TABLET in 1 BOTTLE (71930-066-52)	500 tablet	2021-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS USP Rx only	Eywa Pharma Inc \| Hibrow Healthcare Private Limited	2026-05-16	Human Prescription Drug Label	7
BACLOFEN TABLETS USP Rx only	Major Pharmaceuticals \| Legacy Pharmaceutical Packaging	2023-05-04	HUMAN PRESCRIPTION DRUG LABEL	1