Home NDC 64850-841 Dantrolene Sodium
Product NDC 64850-841
11-digit product format 648500841
Labeler code 64850
Product ID 64850-841_e3fc6ec6-cdde-456a-81bd-8ebd07065afc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dantrolene sodium
Dosage form CAPSULE
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA076686
Marketing category ANDA
Marketing start 2005-10-26
Substance DANTROLENE SODIUM
Active strength 50 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 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.
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 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.
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 50 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856652 Internal RxNorm lookup 856656 Internal RxNorm lookup 856660 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 64850-841-01 Dantrolene Sodium 100 in 1 BOTTLE CAPSULE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-841 DANTROLENE SODIUM CAPSULE [ELITE LABORATORIES, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20230420_e637fb20-6a17-4522-810a-990bf1409732.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 · 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 ndc (product): 64850-841
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 64850-841-01 64850084101 100 CAPSULE in 1 BOTTLE (64850-841-01) 100 capsule 2005-10-26 0000-00-00 No No Current