Dantrolene Sodium

Product NDC: 68151-1520
11-digit product format: 681511520
Labeler code: 68151
Product ID: 68151-1520_cbece5e5-72b3-433f-84ae-03013ce93454
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dantrolene Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA076856
Marketing category: ANDA
Marketing start: 2005-03-01
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: E
Listing certified through: 2018-12-31
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	68151-1520		I	Inactivated by FDA		2026-08-03
excluded package	package	68151-1520	68151-1520-0	I	Inactivated by FDA		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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-1520-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-1520-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-1520-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-1520-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-1520-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-1520-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-1520-0	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-1520-0	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-1520-0	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-1520-0	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-1520-0	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-1520-0	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-1520-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-1520-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-1520-0	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-1520-0	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-1520-0	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-1520-0	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-1520-0	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-1520-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-1520-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-1520-0	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A076856-001	DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01
A076856-002	DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01
A076856-003	DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076856-001	AB
A076856-002	AB
A076856-003	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	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-002	DANTROLENE SODIUM	50MG	CAPSULE / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-003	DANTROLENE SODIUM	100MG	CAPSULE / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076856-001	DANTROLENE SODIUM	25MG	CAPSULE / ORAL	AB	2005-03-01	`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	A076856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076856-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076856-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076856-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076856-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076856-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076856-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076856-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076856-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076856-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076856-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076856-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076856-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076856-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076856-001	AB	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-1520-0	2020-01-31	C162847	48780-1	9d75b9d0-8b99-f424-e053-dadaa90a57ce	DANTROLENE SODIUM CAPSULES, 25 mg, 50 mg and 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-1520-0	Dantrolene Sodium	1 in 1 PACKAGE	CAPSULE	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dantrolene Sodium	ACTIVE INGREDIENT	287M0347EV	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
DANTROLENE	ACTIVE MOIETY	F64QU97QCR	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-1520	DANTROLENE SODIUM CAPSULE [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20170706_ade5fe9c-7601-490a-ac6f-31e63fbd3f8d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dantrolene Sodium	DANTROLENE SODIUM	Major Pharmaceuticals	90414d2f-7b2c-47f9-a096-2e7b7dd052de	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	Amneal Pharmaceuticals of New York LLC	c3c45b27-f786-456e-95d6-2e38ef36190a	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	Cardinal Health 107, LLC	5ec05285-4cbd-49c4-951b-86829da6f587	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	AvPAK	bd1ef298-2219-2a01-e053-2995a90abb08	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856
Dantrolene Sodium	DANTROLENE SODIUM	American Health Packaging	5162f162-8454-4c07-9670-682df7c30b0f	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076856 application number: ANDA076856

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
856656	dantrolene sodium 25 MG Oral Capsule	PSN	ade5fe9c-7601-490a-ac6f-31e63fbd3f8d	4
856656	dantrolene sodium 25 MG Oral Capsule	SCD	ade5fe9c-7601-490a-ac6f-31e63fbd3f8d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-1520-0	68151152000	1 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DANTROLENE SODIUM CAPSULES, 25 mg, 50 mg and 100 mg	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4