Chlorzoxazone

Product NDC: 50090-6689
11-digit product format: 500906689
Labeler code: 50090
Product ID: 50090-6689_70999306-c59c-4757-a0d2-c2da07a35e09
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorzoxazone
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA212254
Marketing category: ANDA
Marketing start: 2019-09-12
Substance: CHLORZOXAZONE
Active strength: 500 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-6689		D	Discontinued by firm	2026-08-17
excluded package	package	50090-6689	50090-6689-0	D	Discontinued by firm	2026-08-17
excluded package	package	50090-6689	50090-6689-1	D	Discontinued by firm	2026-08-17
excluded package	package	50090-6689	50090-6689-3	D	Discontinued by firm	2026-08-17
excluded package	package	50090-6689	50090-6689-4	D	Discontinued by firm	2026-08-17

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212254-001	CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET / ORAL	AA		2019-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212254-001	AA

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.

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	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212254-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2019-09-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212254-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212254-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212254-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212254-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212254-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212254-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212254-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212254-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212254-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212254-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212254-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212254-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212254-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212254-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212254-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212254-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212254-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212254-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212254-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212254-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212254-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212254-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212254-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212254-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212254-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212254-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212254-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212254-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212254-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212254-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212254-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212254-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212254-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212254-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212254-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212254-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212254-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212254-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212254-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212254-001	AA	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a7ba9d15-162f-2741-f0fc-3516be5e88bd	Product name	7	20250114
cbf4a4f8-16cb-4546-a0cc-fd91bbe774f2	Product name	2	20240223
0a48cfb8-244e-463e-aa85-fd9bbbc9190a	Product name	2	20200224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-6689-0	Chlorzoxazone	30 in 1 BOTTLE	TABLET	30	1
50090-6689-1	Chlorzoxazone	20 in 1 BOTTLE	TABLET	20	1
50090-6689-3	Chlorzoxazone	60 in 1 BOTTLE	TABLET	60	1
50090-6689-4	Chlorzoxazone	40 in 1 BOTTLE	TABLET	40	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6689	CHLORZOXAZONE TABLET [A-S MEDICATION SOLUTIONS]	1	Current NDC, 4 package rows	20230919_b66e4567-e5cd-484d-8979-2011144dab4c.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
Chlorzoxazone	CHLORZOXAZONE	Bryant Ranch Prepack	267a0a2a-b818-47d9-9b61-28be172de99a	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212254 application number: ANDA212254
Chlorzoxazone	CHLORZOXAZONE	Novitium Pharma LLC	69c87a85-4b6b-405b-9fa5-4c91c0f90c70	2021-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212254 application number: ANDA212254

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0DE420U8G	CHLORZOXAZONE	95-25-0	CHLORZOXAZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6689-0	50090668900	30 TABLET in 1 BOTTLE (50090-6689-0)	30 tablet	2023-09-15	No	No	Historical
50090-6689-1	50090668901	20 TABLET in 1 BOTTLE (50090-6689-1)	20 tablet	2023-09-15	No	No	Historical
50090-6689-3	50090668903	60 TABLET in 1 BOTTLE (50090-6689-3)	60 tablet	2023-09-15	No	No	Historical
50090-6689-4	50090668904	40 TABLET in 1 BOTTLE (50090-6689-4)	40 tablet	2023-09-15	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorzoxazone Tablets, USP 500 mg Novitium Pharma LLC	A-S Medication Solutions	2023-09-18	Human Prescription Drug Label	1