Dantrium

Product NDC: 42023-123
11-digit product format: 420230123
Labeler code: 42023
Product ID: 42023-123_dd4a56ce-80e3-4794-94a8-cb2b14695b89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dantrolene sodium
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Par Health USA, LLC
Application: NDA018264
Marketing category: NDA
Marketing start: 2009-04-20
Substance: DANTROLENE SODIUM
Active strength: 20 mg/60mL
Pharmacologic classes: Decreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018264-001	DANTRIUM	DANTROLENE SODIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018264-001	AP

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 2 · 41 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	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018264-001	DANTRIUM	20MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N018264-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018264-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018264-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018264-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018264-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018264-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018264-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018264-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018264-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018264-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018264-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018264-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018264-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018264-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018264-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018264-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018264-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018264-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018264-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018264-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018264-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018264-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018264-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018264-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018264-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018264-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018264-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018264-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018264-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018264-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018264-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018264-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018264-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018264-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018264-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018264-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018264-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018264-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018264-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018264-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DANTROLENE SODIUM	20 mg/60mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856696	Internal RxNorm lookup
856698	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
4df35098-8702-46be-ac67-30cfdf1aa570	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0e1aa0c0-7e5b-41f6-80ca-71938bc3ba10	Product name	2	20170803
d7dbb6a6-7ce7-4878-a62c-772d63bc4c9f	Product name	2	20141210
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
aa6a0d9e-0b39-aacf-4e4e-ce5e489de585	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42023-123-06	Dantrium	60 mL in 1 VIAL	INJECTION	60		15
42023-123-06	Dantrium	6 in 1 CARTON	INJECTION	6		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-123-06	EA - Each	42023-123	0613ff7c-1443-419d-9c3b-823ee26cb68b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dantrolene sodium	ACTIVE INGREDIENT	287M0347EV	DANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]	5
dantrolene	ACTIVE MOIETY	F64QU97QCR	DANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]	5
mannitol	INACTIVE INGREDIENT	3OWL53L36A	DANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]	5
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	DANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-123	DANTRIUM (DANTROLENE SODIUM) INJECTION [ENDO USA, INC.]	12	Current NDC, Legacy NDC, 2 package rows	20240709_4df35098-8702-46be-ac67-30cfdf1aa570.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dantrium	DANTROLENE SODIUM	Par Health USA, LLC	4df35098-8702-46be-ac67-30cfdf1aa570	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018264 application number: NDA018264 ndc (product): 42023-123

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
856698	Dantrium 0.333 MG/ML Injectable Solution	PSN	4df35098-8702-46be-ac67-30cfdf1aa570	15
856696	dantrolene sodium 0.333 MG/ML Injectable Solution	PSN	4df35098-8702-46be-ac67-30cfdf1aa570	15
856698	dantrolene sodium 0.333 MG/ML Injectable Solution [Dantrium]	SBD	4df35098-8702-46be-ac67-30cfdf1aa570	15
856696	dantrolene sodium 0.333 MG/ML Injectable Solution	SCD	4df35098-8702-46be-ac67-30cfdf1aa570	15
856698	Dantrium 0.333 MG/ML (as dantrolene sodium) Injectable Solution	SY	4df35098-8702-46be-ac67-30cfdf1aa570	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-123-06	42023012306	6 VIAL in 1 CARTON (42023-123-06) / 60 mL in 1 VIAL	6 vial	2009-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dantrium ® Intravenous (dantrolene sodium for injection)	Par Health USA, LLC	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	15