Home NDC 25021-826 zoledronic acid
Product NDC 25021-826
11-digit product format 250210826
Labeler code 25021
Product ID 25021-826_cd9bea2a-6045-452d-9ac5-e70d08e9e26f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zoledronic acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application NDA203231
Marketing category NDA
Marketing start 2013-03-02
Substance ZOLEDRONIC ACID
Active strength .04 mg/mL
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 25021-826-66 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 25021-826-66 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 25021-826-66 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 25021-826-66 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 25021-826-66 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 25021-826-66 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 25021-826-66 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 25021-826-66 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 25021-826-66 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 25021-826-66 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 25021-826-66 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 25021-826-66 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N203231-001 ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203231-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD, RS 2013-08-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD 2013-08-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP RLD 2013-08-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203231-001 ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2013-08-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 .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 25021-826-82 zoledronic acid 1 in 1 CARTON INJECTION, SOLUTION 1 21 25021-826-82 zoledronic acid 100 mL in 1 BAG INJECTION, SOLUTION 100 21 25021-826-87 zoledronic acid 100 mL in 1 BAG INJECTION, SOLUTION 100 21 25021-826-87 zoledronic acid 5 in 1 CARTON INJECTION, SOLUTION 5 21 25021-826-67 zoledronic acid 100 mL in 1 BAG INJECTION, SOLUTION 100 11 25021-826-67 zoledronic acid 1 in 1 CARTON INJECTION, SOLUTION 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded zoledronic acid ACTIVE INGREDIENT 6XC1PAD3KF ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 zoledronic acid anhydrous ACTIVE MOIETY 70HZ18PH24 ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 mannitol INACTIVE INGREDIENT 3OWL53L36A ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 water INACTIVE INGREDIENT 059QF0KO0R ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 zoledronic acid ACTIVE INGREDIENT 6XC1PAD3KF ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 zoledronic acid anhydrous ACTIVE MOIETY 70HZ18PH24 ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 water INACTIVE INGREDIENT 059QF0KO0R ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-826 ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 21 Current NDC, Legacy NDC, 4 package rows 20250325_567578e6-cd2d-4339-b0f6-7a15444c0639.zip 25021-826 ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 11 Current NDC, Legacy NDC, 2 package rows 20220309_deb89be7-f40e-4fd4-a2cb-96634b45da84.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 · 2 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 25021-826-67 25021082667 1 BAG in 1 CARTON (25021-826-67) / 100 mL in 1 BAG 1 bag 2015-09-01 0000-00-00 No No Current 25021-826-82 25021082682 1 BAG in 1 CARTON (25021-826-82) / 100 mL in 1 BAG 1 bag 2013-03-02 0000-00-00 No No Current 25021-826-87 25021082687 5 BAG in 1 CARTON (25021-826-87) / 100 mL in 1 BAG 5 bag 2025-04-15 No No Current