Dantrium

Product NDC: 42023-125
11-digit product format: 420230125
Labeler code: 42023
Product ID: 42023-125_ae3211d2-bff5-47ba-a683-331c32499f62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dantrolene sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: NDA017443
Marketing category: NDA
Marketing start: 2008-08-01
Marketing end: 2022-02-28
Substance: DANTROLENE SODIUM
Active strength: 50 mg/1
Pharmacologic classes: Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42023-125		D	Discontinued by firm		2026-08-03
excluded package	package	42023-125	42023-125-01	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42023-125-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42023-125-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42023-125-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42023-125-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42023-125-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42023-125-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42023-125-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42023-125-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42023-125-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42023-125-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42023-125-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42023-125-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS
N017443-001	DANTRIUM	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017443-002	DANTRIUM	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982
N017443-003	DANTRIUM	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017443-001	AB
N017443-002	AB
N017443-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017443-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017443-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017443-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017443-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017443-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017443-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017443-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017443-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017443-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017443-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017443-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017443-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017443-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017443-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017443-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017443-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017443-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017443-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017443-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017443-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017443-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017443-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017443-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017443-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017443-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017443-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017443-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017443-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017443-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017443-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017443-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017443-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017443-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017443-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017443-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017443-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017443-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017443-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017443-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017443-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e1aa0c0-7e5b-41f6-80ca-71938bc3ba10	Product name	2	20170803
d7dbb6a6-7ce7-4878-a62c-772d63bc4c9f	Product name	2	20141210
aa6a0d9e-0b39-aacf-4e4e-ce5e489de585	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42023-125-01	Dantrium	100 in 1 BOTTLE	CAPSULE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-125-01	EA - Each	42023-125	7478a952-23c4-49d0-a41f-0e6f4415c0ee	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dantrolene sodium	ACTIVE INGREDIENT	287M0347EV	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6
dantrolene	ACTIVE MOIETY	F64QU97QCR	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6
Gelatin	INACTIVE INGREDIENT	2G86QN327L	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-125	DANTRIUM (DANTROLENE SODIUM) CAPSULE [ENDO USA, INC.]	13	Legacy NDC, 1 package rows	20250112_57b4eec1-49e1-432c-95ae-0fe36e32d64b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dantrolene sodium	DANTROLENE SODIUM	REMEDYREPACK INC.	35f62a81-653f-4a3c-a797-d39304dcd08c	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017443 application number: NDA017443
dantrolene sodium	DANTROLENE SODIUM	REMEDYREPACK INC.	c10e7eb1-0155-43ff-aa56-8cd468e8e84d	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017443 application number: NDA017443
dantrolene sodium	DANTROLENE SODIUM	Endo USA, Inc.	11689f56-15e0-4350-b53f-ae96e5994fea	2024-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017443 application number: NDA017443
Dantrium	DANTROLENE SODIUM	Endo USA, Inc.	57b4eec1-49e1-432c-95ae-0fe36e32d64b	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017443 application number: NDA017443 ndc (product): 42023-125
dantrolene sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	f6ce8871-f1a5-43ea-9250-1999fb69b835	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017443 application number: NDA017443
dantrolene sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	db715aef-83ca-4608-befa-8288ab4adeea	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017443 application number: NDA017443
dantrolene sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	c83daa7b-f2c6-418f-a242-fe2d8cad4081	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017443 application number: NDA017443

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
287M0347EV	DANTROLENE SODIUM	24868-20-0	DANTROLENE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856654	Dantrium 100 MG Oral Capsule	PSN	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856658	Dantrium 25 MG Oral Capsule	PSN	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856662	Dantrium 50 MG Oral Capsule	PSN	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856652	dantrolene sodium 100 MG Oral Capsule	PSN	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856656	dantrolene sodium 25 MG Oral Capsule	PSN	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856660	dantrolene sodium 50 MG Oral Capsule	PSN	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856654	dantrolene sodium 100 MG Oral Capsule [Dantrium]	SBD	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856658	dantrolene sodium 25 MG Oral Capsule [Dantrium]	SBD	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856662	dantrolene sodium 50 MG Oral Capsule [Dantrium]	SBD	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856652	dantrolene sodium 100 MG Oral Capsule	SCD	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856656	dantrolene sodium 25 MG Oral Capsule	SCD	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856660	dantrolene sodium 50 MG Oral Capsule	SCD	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856654	Dantrium 100 MG Oral Capsule	SY	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856658	Dantrium 25 MG Oral Capsule	SY	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13
856662	Dantrium 50 MG Oral Capsule	SY	57b4eec1-49e1-432c-95ae-0fe36e32d64b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-125-01	42023012501	100 CAPSULE in 1 BOTTLE (42023-125-01)	100 capsule	2008-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dantrium ® Capsules (dantrolene sodium)	Endo USA, Inc. \| Par Formulations Private Limited	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	13