dantrolene sodium

Product NDC: 70518-4668
Requested package NDC: 70518-4668-0
11-digit product format: 705184668
Labeler code: 70518
Product ID: 70518-4668_53448097-5763-e754-e063-6394a90a1b25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dantrolene sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA017443
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-05-27
Substance: DANTROLENE SODIUM
Active strength: 50 mg/1
Pharmacologic classes: Decreased Striated Muscle Contraction [PE]; Decreased Striated Muscle Tone [PE]; Skeletal Muscle Relaxant [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 06:07:40	2026-07	N017443-001	DANTRIUM	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017443-002	DANTRIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017443-003	DANTRIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017443-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017443-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017443-003	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: dantrolene sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DANTROLENE SODIUM	50 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
856660	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
35f62a81-653f-4a3c-a797-d39304dcd08c	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

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 ndc (package): 70518-4668-0 ndc (product): 70518-4668 ndc11 (package): 70518466800
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
70518-4668-0	70518466800	50 POUCH in 1 BOX (70518-4668-0) / 1 CAPSULE in 1 POUCH (70518-4668-1)	50 pouch	2026-05-27	0	Current