Application 017443

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DANTRIUM	DANTROLENE SODIUM	CAPSULE;ORAL	25MG	Yes	No
002	DANTRIUM	DANTROLENE SODIUM	CAPSULE;ORAL	100MG	Yes	Yes
003	DANTRIUM	DANTROLENE SODIUM	CAPSULE;ORAL	50MG	Yes	No

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…`

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 ndc (product): 49884-364 ndc (product): 49884-363 ndc (product): 49884-362
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): 42023-124 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 ndc (product): 63629-2168
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 ndc (product): 63629-2169
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-124	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-124	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-125	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-125	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-144	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-362	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-363	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-364	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
63629-2168	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2168	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2168	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2169	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2169	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2169	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2170	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2170	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33270	SUPPL	2012-07-19
10994	SUPPL	2012-07-19
10993	SUPPL	2012-07-19
10992	SUPPL	2012-07-19
13142	SUPPL	2012-07-18
13141	SUPPL	2012-07-18
589	SUPPL	2012-07-18
588	SUPPL	2012-07-18