Home NDC 43066-509 Rocuronium Bromide
Product NDC 43066-509
11-digit product format 430660509
Labeler code 43066
Product ID 43066-509_a18fce42-0f3d-4354-845e-57c37ac3a147
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rocuronium Bromide
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA219260
Marketing category ANDA
Marketing start 2026-09-18
Substance ROCURONIUM BROMIDE
Active strength 100 mg/10mL
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 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 A219260-001 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2026-09-18 A219260-002 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2026-09-18
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.
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 A219260-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2026-09-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219260-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2026-09-18 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A219260-001 AP 1 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219260-002 AP 1 c2088c7a36db…
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 Rocuronium Bromide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROCURONIUM BROMIDE 100 mg/10mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43066-509-05 43066050905 5 CARTON in 1 CARTON (43066-509-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-509-01) / 10 mL in 1 SYRINGE, PLASTIC 5 carton 2026-09-18 No No Current