CHLORZOXAZONE

Product NDC: 55700-951
11-digit product format: 557000951
Labeler code: 55700
Product ID: 55700-951_08b8eb0d-d280-4a23-873e-3089f76df948
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORZOXAZONE
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA089853
Marketing category: ANDA
Marketing start: 2022-01-06
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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-951		D	Discontinued by firm	2026-08-17
excluded package	package	55700-951	55700-951-60	D	Discontinued by firm	2026-08-17
excluded package	package	55700-951	55700-951-90	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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	55700-951		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-951	55700-951-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-951	55700-951-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-951-60	EA - Each	55700-951	bc990c62-a8d3-4460-8caf-831e1b46fc09	1	2022-03-09
55700-951-90	EA - Each	55700-951	9b26c343-8d49-4d16-95ad-768d40b277c4	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-951	CHLORZOXAZONE TABLET [QUALITY CARE PRODUCTS, LLC]	5	Legacy NDC	20241220_5fb93769-91ef-450a-bb35-1c0588b33663.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 · 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-951-60	55700095160	60 TABLET in 1 BOTTLE (55700-951-60)	60 tablet	2022-01-06	0000-00-00	No	No	Current
55700-951-90	55700095190	90 TABLET in 1 BOTTLE (55700-951-90)	90 tablet	2022-01-06	0000-00-00	No	No	Current