Home NDC 68083-256 Zoledronic acid
Product NDC 68083-256
11-digit product format 680830256
Labeler code 68083
Product ID 68083-256_a8e4a749-32b9-41fd-8dbc-9451e97cf001
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zoledronic acid
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA209578
Marketing category ANDA
Marketing start 2017-03-13
Substance ZOLEDRONIC ACID
Active strength 5 mg/100mL
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 A209578-001 ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209578-001 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 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209578-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2019-08-08 a50c72e98297…
Observed Orange Book normalized TE history# 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 5 mg/100mL
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 705824 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 68083-256-01 Zoledronic acid 100 mL in 1 BAG INJECTION 100 7 68083-256-01 Zoledronic acid 1 in 1 CARTON INJECTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-256 ZOLEDRONIC ACID INJECTION [GLAND PHARMA LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20230310_d761011b-edd6-4d3f-bacd-8607dc2414fc.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68083-256-01 68083025601 1 BAG in 1 CARTON (68083-256-01) / 100 mL in 1 BAG 1 bag 2017-03-13 0000-00-00 No No Current