Home NDC 0121-1075 Brivaracetam
Product NDC 0121-1075
11-digit product format 001211075
Labeler code 0121
Product ID 0121-1075_c0702161-ae73-4aac-b6fd-fb3fa7c841b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brivaracetam Injection
Dosage form INJECTION
Route INTRAVENOUS
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA218249
Marketing category ANDA
Marketing start 2026-02-23
Substance BRIVARACETAM
Active strength 50 mg/5mL
Pharmacologic classes Epoxide Hydrolase Inhibitors [MoA]
DEA schedule CV
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218249-001 BRIVARACETAM BRIVARACETAM 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218249-001 AP
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218249-001 BRIVARACETAM 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218249-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Brivaracetam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIVARACETAM 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U863JGG2IA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1739749 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 0121-1075-02 Brivaracetam 10 in 1 CARTON INJECTION 10 3 0121-1075-55 Brivaracetam 5 mL in 1 VIAL, GLASS INJECTION 5 3
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 Units Marketing start Sample Exclude flag Status 0121-1075-02 00121107502 10 VIAL, GLASS in 1 CARTON (0121-1075-02) / 5 mL in 1 VIAL, GLASS (0121-1075-55) 2026-02-23 No No Current 0121-1075-55 00121107555 5 mL in 1 VIAL, GLASS 5 ml Historical