Home NDC 54288-100 Zoledronic Acid
Product NDC 54288-100
11-digit product format 542880100
Labeler code 54288
Product ID 54288-100_fd8bf083-6f6b-44db-bc6d-5368522b83d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zoledronic acid
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler BPI Labs LLC
Application ANDA207341
Marketing category ANDA
Marketing start 2018-04-02
Substance ZOLEDRONIC ACID
Active strength 4 mg/5mL
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A207341-001 ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207341-001 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.
Product history page 1 of 2 · 41 observed 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 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207341-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2017-12-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zoledronic Acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLEDRONIC ACID 4 mg/5mL
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 351114 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 54288-100-01 Zoledronic Acid 5 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 5 14 54288-100-01 Zoledronic Acid 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54288-100 ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [BPI LABS, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20250213_634e9d4b-e940-4743-ad39-794dad28d79b.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 · 1 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 54288-100-01 54288010001 1 VIAL in 1 CARTON (54288-100-01) / 5 mL in 1 VIAL 1 vial 2018-04-02 0000-00-00 No No Current