CHLORZOXAZONE

Product NDC: 71205-711
11-digit product format: 712050711
Labeler code: 71205
Product ID: 71205-711_8b8a3310-04e1-4930-8c69-9f8d470b8925
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORZOXAZONE
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA089853
Marketing category: ANDA
Marketing start: 2020-08-03
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A089853-001	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	1988-05-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-002	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2023-08-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2023-08-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A089853-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A089853-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 71205-711
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORZOXAZONE	500 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197502	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
0a8ee5fa-f393-4568-81bd-269f9a4cecd6	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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-711-20	CHLORZOXAZONE	20 in 1 BOTTLE	TABLET	20	2
71205-711-30	CHLORZOXAZONE	30 in 1 BOTTLE	TABLET	30	2
71205-711-60	CHLORZOXAZONE	60 in 1 BOTTLE	TABLET	60	2
71205-711-90	CHLORZOXAZONE	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-711-20	EA - Each	71205-711	b9b64c97-2cc3-4b4d-bc5a-edd86f105216	1	2025-06-13
71205-711-30	EA - Each	71205-711	83a22147-d196-44e6-b878-0eb23a65e9fe	1	2022-12-07
71205-711-90	EA - Each	71205-711	4cbcbcb5-77ec-4320-8fc7-50fcf4ce2f3a	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-711	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 4 package rows	20250321_0a8ee5fa-f393-4568-81bd-269f9a4cecd6.zip

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	0a8ee5fa-f393-4568-81bd-269f9a4cecd6	2
197502	chlorzoxazone 500 MG Oral Tablet	SCD	0a8ee5fa-f393-4568-81bd-269f9a4cecd6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-711-20	71205071120	20 TABLET in 1 BOTTLE (71205-711-20)	20 tablet	2025-03-12		No	No	Current
71205-711-30	71205071130	30 TABLET in 1 BOTTLE (71205-711-30)	30 tablet	2022-11-03	0000-00-00	No	No	Current
71205-711-60	71205071160	60 TABLET in 1 BOTTLE (71205-711-60)	60 tablet	2022-11-03	0000-00-00	No	No	Current
71205-711-90	71205071190	90 TABLET in 1 BOTTLE (71205-711-90)	90 tablet	2022-11-03	0000-00-00	No	No	Current