Chlorzoxazone

Product NDC: 0591-2520
11-digit product format: 005912520
Labeler code: 0591
Product ID: 0591-2520_9ea218a7-b12c-4aec-9c0b-3104b03649ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorzoxazone
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA089859
Marketing category: ANDA
Marketing start: 2011-08-22
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

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 Identifiers#

Field, Values table
Field	Values
Unii	H0DE420U8G
Rxcui	197502

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
0a48cfb8-244e-463e-aa85-fd9bbbc9190a	Product name	2	20200224
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2520-01	Chlorzoxazone	100 in 1 BOTTLE, PLASTIC	TABLET	100		15
0591-2520-05	Chlorzoxazone	500 in 1 BOTTLE, PLASTIC	TABLET	500		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2520-01	EA - Each	0591-2520	c68b0735-e584-41ca-bb99-0be350eaaf06	1	2012-07-24
0591-2520-05	EA - Each	0591-2520	ccc38ea1-8e08-4350-9e63-93d3fa49cd0b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORZOXAZONE	ACTIVE INGREDIENT	H0DE420U8G	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
CHLORZOXAZONE	ACTIVE MOIETY	H0DE420U8G	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
CHLORZOXAZONE	ACTIVE INGREDIENT	H0DE420U8G	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
CHLORZOXAZONE	ACTIVE MOIETY	H0DE420U8G	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	7
CHLORZOXAZONE	ACTIVE INGREDIENT	H0DE420U8G	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
CHLORZOXAZONE	ACTIVE MOIETY	H0DE420U8G	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORZOXAZONE TABLET [REBEL DISTRIBUTORS CORP]	3
CHLORZOXAZONE	ACTIVE INGREDIENT	H0DE420U8G	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
CHLORZOXAZONE	ACTIVE INGREDIENT	H0DE420U8G	CHLORZOXAZONE TABLET [DIRECT RX]	2
CHLORZOXAZONE	ACTIVE INGREDIENT	H0DE420U8G	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
CHLORZOXAZONE	ACTIVE MOIETY	H0DE420U8G	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
CHLORZOXAZONE	ACTIVE MOIETY	H0DE420U8G	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
CHLORZOXAZONE	ACTIVE MOIETY	H0DE420U8G	CHLORZOXAZONE TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORZOXAZONE TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CHLORZOXAZONE TABLET [DIRECT RX]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORZOXAZONE TABLET [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORZOXAZONE TABLET [DIRECT RX]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORZOXAZONE TABLET [DIRECT RX]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORZOXAZONE TABLET [DIRECT RX]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORZOXAZONE TABLET [DIRECT RX]	2
CHLORZOXAZONE	ACTIVE INGREDIENT	H0DE420U8G	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
CHLORZOXAZONE	ACTIVE MOIETY	H0DE420U8G	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORZOXAZONE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2520	CHLORZOXAZONE TABLET [ACTAVIS PHARMA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20240925_2f05e8e2-616f-475b-ac9f-c42e1a5dbe81.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	8650d342-92df-48d7-9f3d-cdd6f6f4c0e7	30
197502	chlorzoxazone 500 MG Oral Tablet	SCD	8650d342-92df-48d7-9f3d-cdd6f6f4c0e7	30
197502	chlorzoxazone 500 MG Oral Tablet	PSN	6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8	21
197502	chlorzoxazone 500 MG Oral Tablet	SCD	6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8	21
197502	chlorzoxazone 500 MG Oral Tablet	PSN	2f05e8e2-616f-475b-ac9f-c42e1a5dbe81	15
197502	chlorzoxazone 500 MG Oral Tablet	SCD	2f05e8e2-616f-475b-ac9f-c42e1a5dbe81	15
197502	chlorzoxazone 500 MG Oral Tablet	PSN	75305abd-a545-401e-8ab7-c9c5edfc91f1	14
197502	chlorzoxazone 500 MG Oral Tablet	SCD	75305abd-a545-401e-8ab7-c9c5edfc91f1	14
197502	chlorzoxazone 500 MG Oral Tablet	PSN	5e6889c9-a091-4622-0a00-ad0fc1830f78	9
197502	chlorzoxazone 500 MG Oral Tablet	SCD	5e6889c9-a091-4622-0a00-ad0fc1830f78	9
197502	chlorzoxazone 500 MG Oral Tablet	PSN	0ed64990-f2f2-40e9-be91-874f0a862f83	6
197502	chlorzoxazone 500 MG Oral Tablet	SCD	0ed64990-f2f2-40e9-be91-874f0a862f83	6
197502	chlorzoxazone 500 MG Oral Tablet	PSN	63338935-f3dd-4ef1-bb66-856a83c95f41	5
197502	chlorzoxazone 500 MG Oral Tablet	PSN	3c3c0279-a570-4ded-9f52-5ef345a6753b	5
197502	chlorzoxazone 500 MG Oral Tablet	SCD	63338935-f3dd-4ef1-bb66-856a83c95f41	5
197502	chlorzoxazone 500 MG Oral Tablet	SCD	3c3c0279-a570-4ded-9f52-5ef345a6753b	5
197502	chlorzoxazone 500 MG Oral Tablet	PSN	9437b8ac-4f0e-4e5d-b699-23c492bf28ab	3
197502	chlorzoxazone 500 MG Oral Tablet	SCD	9437b8ac-4f0e-4e5d-b699-23c492bf28ab	3
197502	chlorzoxazone 500 MG Oral Tablet	PSN	63f43b2a-dd5b-482c-a00c-7643d91c2292	2
197502	chlorzoxazone 500 MG Oral Tablet	SCD	63f43b2a-dd5b-482c-a00c-7643d91c2292	2
197502	chlorzoxazone 500 MG Oral Tablet	PSN	720357e2-6f14-737d-e053-2a95a90ae54b	1
197502	chlorzoxazone 500 MG Oral Tablet	SCD	720357e2-6f14-737d-e053-2a95a90ae54b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2520-00	00591252000	14080 TABLET in 1 BOX (0591-2520-00)	14080 tablet	22-AUG-11				Current
0591-2520-01	00591252001	100 TABLET in 1 BOTTLE, PLASTIC (0591-2520-01)	100 tablet	2011-08-22	0000-00-00	No	No	Current
0591-2520-05	00591252005	500 TABLET in 1 BOTTLE, PLASTIC (0591-2520-05)	500 tablet	2011-08-22	0000-00-00	No	No	Current
0591-2520-77	00591252077	16896 TABLET in 1 CONTAINER (0591-2520-77)	16896 tablet	22-JUL-24				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorzoxazone Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	30
Chlorzoxazone Tablets, USP Rx only	Bryant Ranch Prepack	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	9
Chlorzoxazone Tablets, USP Rx only	Actavis Pharma, Inc.	2024-08-25	HUMAN PRESCRIPTION DRUG LABEL	15
Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1	A-S Medication Solutions	2023-03-08	HUMAN PRESCRIPTION DRUG LABEL	21
CHLORZOXAZONE	DIRECT RX	2022-10-11	HUMAN PRESCRIPTION DRUG LABEL	6
CHLORZOXAZONE TABLETS, USP 500 mg Revised: November 2010 Rx only 195609	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1	A-S Medication Solutions	2020-01-27	HUMAN PRESCRIPTION DRUG LABEL	14
Chlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1	Medsource Pharmaceuticals	2018-07-27	HUMAN PRESCRIPTION DRUG LABEL	1
CHLORZOXAZONE TABLETS, USP 500 mg Revised: November 2010 Rx only 195609	Aidarex Pharmaceuticals LLC	2012-09-14	HUMAN PRESCRIPTION DRUG LABEL	2
CHLORZOXAZONE TABLETS, USP 500 mg Revised: November 2010 Rx only 195609	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-01-24	HUMAN PRESCRIPTION DRUG LABEL	3

Chlorzoxazone

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#