CHLORZOXAZONE

Product NDC: 80425-0525
11-digit product format: 804250525
Labeler code: 80425
Product ID: 80425-0525_36c1e480-6aa2-03e2-e063-6294a90a7280
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORZOXAZONE
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA089853
Marketing category: ANDA
Marketing start: 2025-05-29
Substance: CHLORZOXAZONE
Active strength: 375 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

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
A089853-001	CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04
A089853-002	CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17
A089853-003	CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089853-001	AA
A089853-002	AB
A089853-003	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 · 84 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	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A089853-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089853-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089853-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089853-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089853-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089853-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089853-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089853-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089853-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089853-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089853-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089853-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089853-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089853-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089853-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089853-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089853-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089853-001	AA	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: CHLORZOXAZONE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORZOXAZONE	375 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H0DE420U8G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1088934	Internal RxNorm lookup
1088936	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
36c1eb43-8840-8d84-e063-6394a90addca	Available on FDA.report

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
80425-0525-1	CHLORZOXAZONE	30 in 1 BOTTLE	TABLET	30	1
80425-0525-2	CHLORZOXAZONE	60 in 1 BOTTLE	TABLET	60	1
80425-0525-3	CHLORZOXAZONE	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0525-1	EA - Each	80425-0525	df95cea7-2329-4f84-b62e-0c1872f866a5	1	2025-07-08
80425-0525-2	EA - Each	80425-0525	33c2efc9-4743-42f8-a8be-9c88acafb05d	1	2025-07-08
80425-0525-3	EA - Each	80425-0525	94f975a5-7701-4ff6-9f01-ab95fafc31aa	1	2025-07-08

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORZOXAZONE	CHLORZOXAZONE	REMEDYREPACK INC.	3f73a1d1-b3ee-4678-bc02-3258ec812127	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853
CHLORZOXAZONE	CHLORZOXAZONE	Advanced Rx of Tennessee, LLC	36c1eb43-8840-8d84-e063-6394a90addca	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853 ndc (product): 80425-0525
CHLORZOXAZONE	CHLORZOXAZONE	Proficient Rx LP	0a8ee5fa-f393-4568-81bd-269f9a4cecd6	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853
Chlorzoxazone	CHLORZOXAZONE	Advanced Rx Pharmacy of Tennessee, LLC	f8ff7293-89b6-b6ee-e053-6394a90a7d39	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853
CHLORZOXAZONE	CHLORZOXAZONE	Bryant Ranch Prepack	669afcc1-d587-4dc0-8f6e-99109bcfed36	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853
CHLORZOXAZONE	CHLORZOXAZONE	Aurobindo Pharma Limited	52d3aa2c-f88f-4de7-b5ae-df8a46e94879	2023-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089853 application number: ANDA089853

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
1088934	chlorzoxazone 375 MG Oral Tablet	PSN	36c1eb43-8840-8d84-e063-6394a90addca	1
1088936	chlorzoxazone 750 MG Oral Tablet	PSN	36c1eb43-8840-8d84-e063-6394a90addca	1
1088934	chlorzoxazone 375 MG Oral Tablet	SCD	36c1eb43-8840-8d84-e063-6394a90addca	1
1088936	chlorzoxazone 750 MG Oral Tablet	SCD	36c1eb43-8840-8d84-e063-6394a90addca	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0525-1	80425052501	30 TABLET in 1 BOTTLE (80425-0525-1)	30 tablet	2025-05-29	No	No	Current
80425-0525-2	80425052502	60 TABLET in 1 BOTTLE (80425-0525-2)	60 tablet	2025-05-29	No	No	Current
80425-0525-3	80425052503	90 TABLET in 1 BOTTLE (80425-0525-3)	90 tablet	2025-05-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorzoxazone Tablets, USP	Advanced Rx of Tennessee, LLC	2025-05-29	HUMAN PRESCRIPTION DRUG LABEL	1