Dantrolene Sodium

Product NDC: 68084-300
11-digit product format: 680840300
Labeler code: 68084
Product ID: 68084-300_259da864-9b15-9e66-e063-6294a90a9b4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dantrolene Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076856
Marketing category: ANDA
Marketing start: 2008-09-29
Substance: DANTROLENE SODIUM
Active strength: 25 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: 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
A076856-001	DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01
A076856-002	DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01
A076856-003	DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076856-001	AB
A076856-002	AB
A076856-003	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 · 129 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	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A076856-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076856-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076856-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076856-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076856-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076856-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-001	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: Dantrolene Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DANTROLENE SODIUM	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
287M0347EV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856656	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
5162f162-8454-4c07-9670-682df7c30b0f	Available on FDA.report

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
68084-300-11	Dantrolene Sodium	1 in 1 BLISTER PACK	CAPSULE	1		9
68084-300-21	Dantrolene Sodium	30 in 1 BOX, UNIT-DOSE	CAPSULE	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-300-11	EA - Each	68084-300	94b780b8-40d4-4d10-8ee7-4177ce2b4aed	1	2012-07-24
68084-300-21	EA - Each	68084-300	f2faaf56-3dbc-42a9-84fc-503df36c8879	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dantrolene Sodium	ACTIVE INGREDIENT	287M0347EV	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
DANTROLENE	ACTIVE MOIETY	F64QU97QCR	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-300	DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING]	9	Current NDC, Legacy NDC, 2 package rows	20241031_5162f162-8454-4c07-9670-682df7c30b0f.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dantrolene Sodium	DANTROLENE SODIUM	Major Pharmaceuticals	90414d2f-7b2c-47f9-a096-2e7b7dd052de	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	Amneal Pharmaceuticals of New York LLC	c3c45b27-f786-456e-95d6-2e38ef36190a	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	Cardinal Health 107, LLC	5ec05285-4cbd-49c4-951b-86829da6f587	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	AvPAK	bd1ef298-2219-2a01-e053-2995a90abb08	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	American Health Packaging	5162f162-8454-4c07-9670-682df7c30b0f	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856 ndc (product): 68084-300

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
856656	dantrolene sodium 25 MG Oral Capsule	PSN	5162f162-8454-4c07-9670-682df7c30b0f	9
856656	dantrolene sodium 25 MG Oral Capsule	PSN	5ec05285-4cbd-49c4-951b-86829da6f587	9
856656	dantrolene sodium 25 MG Oral Capsule	SCD	5162f162-8454-4c07-9670-682df7c30b0f	9
856656	dantrolene sodium 25 MG Oral Capsule	SCD	5ec05285-4cbd-49c4-951b-86829da6f587	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-300-11	68084030011	1 in 1 BLISTER PACK						Historical
68084-300-21	68084030021	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-300-21) / 1 CAPSULE in 1 BLISTER PACK (68084-300-11)	30 blister pack	2008-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dantrolene Sodium Capsules, USP 8230021/0721 Rx only	Cardinal Health 107, LLC	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	9
Dantrolene Sodium Capsules, USP 8230021/0721 Rx only	American Health Packaging	2024-10-29	HUMAN PRESCRIPTION DRUG LABEL	9