Home NDC 65145-135-10 Cisatracurium besylate
Product NDC 65145-135
Requested package NDC 65145-135-10
11-digit product format 651450135
Labeler code 65145
Product ID 65145-135_984769d6-523a-4e06-aaa7-ccbb039e38ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisatracurium besylate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Caplin Steriles Limited
Application ANDA217725
Marketing category ANDA
Marketing start 2025-01-17
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 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 A217725-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 A217725-002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09
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 · 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 2026-02-19 14:30 UTC 2026-02 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION 2023-06-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-06-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217725-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217725-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-06-09 a67488948f0b…
Observed Orange Book normalized TE history# 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 · 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 65145-135-01 Cisatracurium besylate 1 in 1 CARTON INJECTION 1 2 65145-135-01 Cisatracurium besylate 5 mL in 1 VIAL, SINGLE-USE INJECTION 5 2 65145-135-10 Cisatracurium besylate 10 in 1 CARTON INJECTION 10 2 65145-135-10 Cisatracurium besylate 5 mL in 1 VIAL, SINGLE-USE INJECTION 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65145-135 CISATRACURIUM BESYLATE INJECTION [CAPLIN STERILES LIMITED] 2 Current NDC, 4 package rows 20250119_93101770-10a1-4bad-a762-289c793d8ace.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65145-135-10 65145013510 10 VIAL, SINGLE-USE in 1 CARTON (65145-135-10) / 5 mL in 1 VIAL, SINGLE-USE 2025-01-17 No No Current