Home NDC 0409-1208 Cisatracurium Besylate
Product NDC 0409-1208
11-digit product format 004091208
Labeler code 0409
Product ID 0409-1208_7b64e51a-1a55-4949-ac7c-b0a21cbd6ec9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CISATRACURIUM BESYLATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA203238
Marketing category ANDA
Marketing start 2020-03-24
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 2027-12-31
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 A203238-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203238-001 AP
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 · 42 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 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2018-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2018-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2018-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2018-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203238-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cisatracurium Besylate
Listing expiration 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199211 Internal RxNorm lookup 199212 Internal RxNorm lookup 1730194 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 0409-1208-01 Cisatracurium Besylate 10 in 1 CARTON INJECTION, SOLUTION 10 15 0409-1208-11 Cisatracurium Besylate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1208 CISATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20240412_67908e20-044d-454d-9c51-bf106e817bd0.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 Units Marketing start Marketing end Sample Exclude flag Status 0409-1208-01 00409120801 10 VIAL, MULTI-DOSE in 1 CARTON (0409-1208-01) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1208-11) 2020-03-24 0000-00-00 No No Current 0409-1208-11 00409120811 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical