Home NDC 68084-300 Dantrolene Sodium
Product NDC 68084-300
11-digit product format 680840300
Labeler code 68084
Product ID 68084-300_259da864-9b15-9e66-e063-6294a90a9b4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dantrolene Sodium
Dosage form CAPSULE
Route ORAL
Labeler American Health Packaging
Application ANDA076856
Marketing category ANDA
Marketing start 2008-09-29
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 2026-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS 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.
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Dantrolene Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DANTROLENE SODIUM 25 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856656 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68084-300-11 Dantrolene Sodium 1 in 1 BLISTER PACK CAPSULE 1 9 68084-300-21 Dantrolene Sodium 30 in 1 BOX, UNIT-DOSE CAPSULE 30 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-300 DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING] 9 Current NDC, Legacy NDC, 2 package rows 20241031_5162f162-8454-4c07-9670-682df7c30b0f.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 ndc (product): 68084-300
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68084-300-11 68084030011 1 in 1 BLISTER PACK Historical 68084-300-21 68084030021 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-300-21) / 1 CAPSULE in 1 BLISTER PACK (68084-300-11) 30 blister pack 2008-09-29 0000-00-00 No No Current