Home NDC 0143-9160 Cisatracurium Besylate
Product NDC 0143-9160
11-digit product format 001439160
Labeler code 0143
Product ID 0143-9160_6c1a13e7-546c-4b06-8217-73f2c4b7ed57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisatracurium Besylate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA203078
Marketing category ANDA
Marketing start 2025-03-17
Substance CISATRACURIUM BESYLATE
Active strength 10 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 42 .
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 A203078-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 A203078-002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18
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 2 · 47 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 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203078-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A203078-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203078-001 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203078-001 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203078-001 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203078-001 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203078-001 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203078-001 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2022-06-28 053a50430f4f…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 observed states.
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 10 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 0143-9160-01 Cisatracurium Besylate 20 mL in 1 VIAL INJECTION 20 4 0143-9160-10 Cisatracurium Besylate 10 in 1 CARTON INJECTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9160 CISATRACURIUM BESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, 2 package rows 20250516_c5a63679-0c94-4e9d-9ac0-8ee3023bd9a6.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 Sample Exclude flag Status 0143-9160-01 00143916001 20 mL in 1 VIAL 20 ml Historical 0143-9160-10 00143916010 10 VIAL in 1 CARTON (0143-9160-10) / 20 mL in 1 VIAL (0143-9160-01) 10 vial 2025-03-17 No No Current