Home NDC 71288-720 Cisatracurium Besylate
Product NDC 71288-720
11-digit product format 712880720
Labeler code 71288
Product ID 71288-720_8b571399-d78e-4ff1-b1ec-20112b898aac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisatracurium Besylate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA211668
Marketing category ANDA
Marketing start 2019-10-31
Marketing end 0000-00-00
Substance CISATRACURIUM BESYLATE
Active strength 10 mg/5mL
Pharmacologic classes Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 71288-720-96 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 71288-720-96 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211668-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 A211668-002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP RS 2019-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211668-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211668-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2019-04-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-720 CISATRACURIUM BESYLATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 3 Legacy NDC 20240402_0a44a430-de51-47c6-9f73-32390e2a0629.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71288-720-96 71288072096 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-720-96) > 5 mL in 1 VIAL, SINGLE-DOSE (71288-720-95) 2019-10-31 0000-00-00 No No Current