Home NDC 83634-655 Cisatracurium Besylate
Product NDC 83634-655
11-digit product format 836340655
Labeler code 83634
Product ID 83634-655_53f69aa3-898e-476d-b18c-573487371a10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cisatracurium besylate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avenacy, LLC
Application ANDA216539
Marketing category ANDA
Marketing start 2026-08-15
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 2027-12-31
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 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27
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.
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 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION 2024-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION 2024-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION 2024-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2024-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION 2024-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216539-001 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216539-002 CISATRACURIUM BESYLATE PRESERVATIVE FREE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-08-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199212 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83634-655-20 83634065520 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-655-20) / 20 mL in 1 VIAL, SINGLE-DOSE (83634-655-41) 2026-08-15 No No Current