CHLORZOXAZONE

Product NDC: 80175-0085
Requested package NDC: 80175-0085-9
11-digit product format: 801750085
Labeler code: 80175
Product ID: 80175-0085_bd99bd77-520e-5cb2-e053-2995a90a6eb0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORZOXAZONE
Dosage form: TABLET
Route: ORAL
Labeler: Central Packaging
Application: ANDA212254
Marketing category: ANDA
Marketing start: 2019-09-12
Marketing end: 0000-00-00
Substance: CHLORZOXAZONE
Active strength: 500 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80175-0085	80175-0085-9	I	Inactivated by FDA		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 · 19 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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	Strength	SPL version
80175-0085-9	CHLORZOXAZONE	90 in 1 BOTTLE	TABLET	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80175-0085	CHLORZOXAZONE TABLET [CENTRAL PACKAGING]	1	Legacy NDC, 1 package rows	20210307_bccfb7cb-f8af-1a85-e053-2a95a90ad052.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197502	chlorzoxazone 500 MG Oral Tablet	PSN	bccfb7cb-f8af-1a85-e053-2a95a90ad052	1
197502	chlorzoxazone 500 MG Oral Tablet	SCD	bccfb7cb-f8af-1a85-e053-2a95a90ad052	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80175-0085-9	80175008509	90 TABLET in 1 BOTTLE (80175-0085-9)	90 tablet	2019-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHLORZOXAZONE - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-03-05	HUMAN PRESCRIPTION DRUG LABEL	1