Chlorzoxazone

Product NDC: 42494-427
11-digit product format: 424940427
Labeler code: 42494
Product ID: 42494-427_02713cab-1cda-4049-8232-9b7bd136d401
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorzoxazone
Dosage form: TABLET
Route: ORAL
Labeler: Cameron Pharmaceuticals
Application: ANDA212254
Marketing category: ANDA
Marketing start: 2019-11-27
Marketing end: 0000-00-00
Substance: CHLORZOXAZONE
Active strength: 500 ug/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42494-427		D	Discontinued by firm		2026-08-17
excluded package	package	42494-427	42494-427-50	D	Discontinued by firm		2026-08-17

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42494-427-50	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42494-427-50	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42494-427-50	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42494-427-50	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42494-427-50	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42494-427-50	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42494-427-50	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42494-427-50	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42494-427-50	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42494-427-50	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42494-427-50	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42494-427-50	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42494-427-50	Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42494-427	CHLORZOXAZONE TABLET [CAMERON PHARMACEUTICALS]	3	Legacy NDC	20200717_b194abb5-f66d-41c3-85a0-5818bed2115d.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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorzoxazone Tablets, USP 500 mg	Cameron Pharmaceuticals \| Novitium Pharma, LLC	2020-03-26	HUMAN PRESCRIPTION DRUG LABEL	3