Home NDC 66794-246 Cisatracurium besylate
Product NDC 66794-246
11-digit product format 667940246
Labeler code 66794
Product ID 66794-246_e2719e22-2218-2d0c-e053-2a95a90a5b94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisatracurium besylate
Dosage form INJECTION
Route INTRAVENOUS
Labeler PIRAMAL CRITICAL CARE INC
Application ANDA215516
Marketing category ANDA
Marketing start 2022-08-01
Marketing end 0000-00-00
Substance CISATRACURIUM BESYLATE
Active strength 200 mg/20mL
Pharmacologic classes Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66794-246-41 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66794-246-41 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215516-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 A215516-002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 A215516-003 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14
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 2 · 76 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 2026-08-18 06:07:40 2026-07 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215516-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215516-003 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215516-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-05-24 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66794-246-02 66794024602 20 mL in 1 VIAL (66794-246-02) 20 ml 2022-08-01 0000-00-00 No No Current