Home NDC 68083-672 zoledronic acid
Product NDC 68083-672
11-digit product format 680830672
Labeler code 68083
Product ID 68083-672_557bde97-d062-4ad7-b8f4-deb2c5112403
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zoledronic acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA219984
Marketing category ANDA
Marketing start 2026-02-05
Substance ZOLEDRONIC ACID
Active strength .04 mg/mL
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
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 A219984-001 ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2026-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219984-001 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 2026-02-19 14:30 UTC 2026-02 A219984-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2026-02-05 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219984-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2026-02-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219984-001 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219984-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base zoledronic acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLEDRONIC ACID .04 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6XC1PAD3KF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1114085 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 68083-672-01 zoledronic acid 1 in 1 CARTON INJECTION, SOLUTION 1 4 68083-672-01 zoledronic acid 100 mL in 1 BAG INJECTION, SOLUTION 100 4
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 68083-672-01 68083067201 1 BAG in 1 CARTON (68083-672-01) / 100 mL in 1 BAG 1 bag 2026-02-05 No No Current