dantrolene sodium

Product NDC: 63629-2170
11-digit product format: 636292170
Labeler code: 63629
Product ID: 63629-2170_353b57e7-8fa2-4317-a9b5-e49b123a485c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dantrolene sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA017443
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-03-28
Marketing end: 0000-00-00
Substance: DANTROLENE SODIUM
Active strength: 100 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: 2023-12-31
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	63629-2170		D	Discontinued by firm		2026-08-03
excluded package	package	63629-2170	63629-2170-1	D	Discontinued by firm		2026-08-03

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2170-1	EA - Each	63629-2170	e54fe3ee-5768-4b6b-b5a4-bbf2e1494613	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2170	DANTROLENE SODIUM CAPSULE [BRYANT RANCH PREPACK]	102	Legacy NDC	20240112_11850cd6-da36-4d83-b385-0abd3122ed96.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
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	Marketing end	Sample	Exclude flag	Status
63629-2170-1	63629217001	100 CAPSULE in 1 BOTTLE (63629-2170-1)	100 capsule	2021-03-12	0000-00-00	No	No	Current