Home NDC 70436-113 Cisatracurium besylate
Product NDC 70436-113
11-digit product format 704360113
Labeler code 70436
Product ID 70436-113_14793b7b-0e90-7b75-e063-6394a90a9c5a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisatracurium besylate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA216538
Marketing category ANDA
Marketing start 2023-12-01
Substance CISATRACURIUM BESYLATE
Active strength 2 mg/mL
Pharmacologic classes Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [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 42 .
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 A216538-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-03-08
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.
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 2026-08-18 06:07:40 2026-07 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-03-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-03-08 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216538-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-03-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cisatracurium besylate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CISATRACURIUM BESYLATE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80YS8O1MBS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199211 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 70436-113-82 Cisatracurium besylate 10 in 1 CARTON INJECTION 10 2 70436-113-82 Cisatracurium besylate 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-113 CISATRACURIUM BESYLATE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 2 Current NDC, 2 package rows 20240326_e06c4d57-bfc7-45ad-b1cd-b5b88dc43b50.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70436-113-82 70436011382 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-113-82) / 10 mL in 1 VIAL, SINGLE-DOSE 2023-12-01 No No Current