Home NDC 0781-3150 cisatracurium besylate
Product NDC 0781-3150
11-digit product format 007813150
Labeler code 0781
Product ID 0781-3150_e26cdb06-a79d-44f0-a4c2-a0cc4e35ca87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cisatracurium besylate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA200154
Marketing category ANDA
Marketing start 2012-07-16
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 43 .
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 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03
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 · 86 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 2026-09-14 22:38:34 2026-08 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200154-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200154-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2012-02-03 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0781-3150-75 cisatracurium besylate 5 mL in 1 VIAL INJECTION 5 12 0781-3150-75 cisatracurium besylate 1 in 1 BOX INJECTION 1 12 0781-3150-95 cisatracurium besylate 10 in 1 CARTON INJECTION 10 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3150 CISATRACURIUM BESYLATE INJECTION [SANDOZ INC] 12 Current NDC, Legacy NDC, 3 package rows 20250321_291a55dd-ab45-4660-b513-4ecb729eb051.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 0781-3150-75 00781315075 5 mL in 1 VIAL 5 ml Historical 0781-3150-95 00781315095 10 BOX in 1 CARTON (0781-3150-95) / 1 VIAL in 1 BOX (0781-3150-75) / 5 mL in 1 VIAL 10 box 2012-07-16 0000-00-00 No No Current