Dantrolene Sodium

Product NDC: 0527-3221
11-digit product format: 005273221
Labeler code: 0527
Product ID: 0527-3221_aa8a58a9-7696-4c26-b277-6b4f74cd020e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dantrolene sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA076686
Marketing category: ANDA
Marketing start: 2005-10-26
Marketing end: 0000-00-00
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: 2020-12-31
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	0527-3221		D	Discontinued by firm		2026-08-03
excluded package	package	0527-3221	0527-3221-37	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 · 20 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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`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	0527-3221-37	`ad56d346431e…`	`cc804d4bbf1e…`

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	Approval date
A076686-001	DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24
A076686-002	DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24
A076686-003	DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076686-001	AB
A076686-002	AB
A076686-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076686-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-10-24	`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	A076686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076686-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076686-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076686-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076686-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076686-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076686-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076686-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076686-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076686-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076686-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076686-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076686-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076686-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076686-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0527-3221-37	2024-02-02	C162847	48780-1	1030e365-2587-111a-e063-dadaa90a10e2	Dantrolene Sodium capsules

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-3221-37	EA - Each	0527-3221	a4d216ea-432d-4147-9274-43f01cf0d9e3	1	2019-07-02

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dantrolene Sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	e432a760-40b8-4efa-af2b-18e027ac5ae4	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686
Dantrolene Sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	dbf78d48-71a6-4a9b-bf31-e710b78944f2	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686
Dantrolene Sodium	DANTROLENE SODIUM	Bryant Ranch Prepack	bd218ddb-c133-438c-9545-321ae4b52440	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686
Dantrolene Sodium	DANTROLENE SODIUM	Elite Laboratories, Inc.	e637fb20-6a17-4522-810a-990bf1409732	2019-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076686 application number: ANDA076686

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
0527-3221-37	00527322137	100 CAPSULE in 1 BOTTLE (0527-3221-37)	100 capsule	2005-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dantrolene Sodium capsules	Lannett Company, Inc. \| Elite Laboratories, Inc.	2018-03-01	HUMAN PRESCRIPTION DRUG LABEL	3