CHLORZOXAZONE

Product NDC: 16571-726
11-digit product format: 165710726
Labeler code: 16571
Product ID: 16571-726_b4a7f61d-613e-4d8f-a3fc-37143c6e19c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORZOXAZONE
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA213126
Marketing category: ANDA
Marketing start: 2022-04-05
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 43.

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
A213126-001	CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05
A213126-002	CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2022-04-05
A213126-003	CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213126-001	AB
A213126-002	AA
A213126-003	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 · 96 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
2026-09-14 22:38:34	2026-08	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2022-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2022-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2022-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AA	2022-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213126-002	CHLORZOXAZONE	500MG	TABLET / ORAL	AB	2022-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213126-003	CHLORZOXAZONE	750MG	TABLET / ORAL	AB	2022-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213126-001	CHLORZOXAZONE	375MG	TABLET / ORAL	AB	2022-04-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213126-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213126-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213126-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213126-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213126-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213126-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213126-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213126-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213126-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213126-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213126-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213126-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213126-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213126-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213126-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213126-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213126-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213126-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213126-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213126-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213126-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213126-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213126-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213126-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213126-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213126-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213126-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213126-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213126-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213126-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213126-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213126-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213126-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213126-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213126-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213126-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213126-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213126-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213126-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213126-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197502	Internal RxNorm lookup
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
1df6058b-7bf2-4246-9827-93fa023a5fd4	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
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
16571-726-01	CHLORZOXAZONE	100 in 1 BOTTLE	TABLET	100		4
16571-726-50	CHLORZOXAZONE	500 in 1 BOTTLE	TABLET	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-726-01	EA - Each	16571-726	25444646-6668-4dc8-bc9f-4615166c2091	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-726	CHLORZOXAZONE TABLET [RISING PHARMA HOLDINGS, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20230610_1df6058b-7bf2-4246-9827-93fa023a5fd4.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORZOXAZONE	CHLORZOXAZONE	Advanced Rx of Tennessee, LLC	30c9b3ce-198d-0c16-e063-6394a90a857d	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213126 application number: ANDA213126
CHLORZOXAZONE	CHLORZOXAZONE	A-S Medication Solutions	d0210638-b828-4c05-9669-fd61ef987317	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213126 application number: ANDA213126
CHLORZOXAZONE	CHLORZOXAZONE	Bryant Ranch Prepack	d7f09907-83b2-46cf-947d-fa38dcf88685	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213126 application number: ANDA213126
CHLORZOXAZONE	CHLORZOXAZONE	Rising Pharma Holdings, Inc.	1df6058b-7bf2-4246-9827-93fa023a5fd4	2023-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213126 application number: ANDA213126 ndc (product): 16571-726

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	1df6058b-7bf2-4246-9827-93fa023a5fd4	4
197502	chlorzoxazone 500 MG Oral Tablet	PSN	1df6058b-7bf2-4246-9827-93fa023a5fd4	4
1088936	chlorzoxazone 750 MG Oral Tablet	PSN	1df6058b-7bf2-4246-9827-93fa023a5fd4	4
1088934	chlorzoxazone 375 MG Oral Tablet	SCD	1df6058b-7bf2-4246-9827-93fa023a5fd4	4
197502	chlorzoxazone 500 MG Oral Tablet	SCD	1df6058b-7bf2-4246-9827-93fa023a5fd4	4
1088936	chlorzoxazone 750 MG Oral Tablet	SCD	1df6058b-7bf2-4246-9827-93fa023a5fd4	4
197502	chlorzoxazone 500 MG Oral Tablet	PSN	d7f09907-83b2-46cf-947d-fa38dcf88685	2
197502	chlorzoxazone 500 MG Oral Tablet	SCD	d7f09907-83b2-46cf-947d-fa38dcf88685	2
197502	chlorzoxazone 500 MG Oral Tablet	PSN	30c9b3ce-198d-0c16-e063-6394a90a857d	1
197502	chlorzoxazone 500 MG Oral Tablet	PSN	d0210638-b828-4c05-9669-fd61ef987317	1
197502	chlorzoxazone 500 MG Oral Tablet	SCD	30c9b3ce-198d-0c16-e063-6394a90a857d	1
197502	chlorzoxazone 500 MG Oral Tablet	SCD	d0210638-b828-4c05-9669-fd61ef987317	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-726-01	16571072601	100 TABLET in 1 BOTTLE (16571-726-01)	100 tablet	2022-04-05	0000-00-00	No	No	Current
16571-726-50	16571072650	500 TABLET in 1 BOTTLE (16571-726-50)	500 tablet	2023-04-28		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorzoxazone Tablets, USP	Advanced Rx of Tennessee, LLC	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
Chlorzoxazone Tablets, USP	A-S Medication Solutions	2025-02-04	Human Prescription Drug Label	1
Chlorzoxazone Tablets, USP	Bryant Ranch Prepack	2024-09-09	HUMAN PRESCRIPTION DRUG LABEL	2
Chlorzoxazone Tablets, USP	Rising Pharma Holdings, Inc. \| Graviti Pharmaceuticals Private Limited	2023-06-09	Human Prescription Drug Label	4