Home NDC 0409-1103 Cisatracurium Besylate
Product NDC 0409-1103
11-digit product format 004091103
Labeler code 0409
Product ID 0409-1103_55a7aed0-96b5-426a-a234-0a4418ade4f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CISATRACURIUM BESYLATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA203236
Marketing category ANDA
Marketing start 2019-12-02
Marketing end 2027-01-31
Substance CISATRACURIUM BESYLATE
Active strength 10 mg/mL
Pharmacologic classes Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A203236-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 A203236-002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30
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 · 88 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 2026-10-15 13:18:30 2026-09 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203236-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203236-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2018-03-30 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cisatracurium Besylate Active Ingredients# Ingredient, Strength table Ingredient Strength CISATRACURIUM BESYLATE 10 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-1103-01 Cisatracurium Besylate 10 in 1 CARTON INJECTION, SOLUTION 10 15 0409-1103-11 Cisatracurium Besylate 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1103 CISATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20240412_67908e20-044d-454d-9c51-bf106e817bd0.zip
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 0409-1103-01 00409110301 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1103-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-1103-11) 2019-12-02 2027-01-31 No No Current 0409-1103-11 00409110311 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical