Home NDC 16714-815-01 Zoledronic acid
Product NDC 16714-815
Requested package NDC 16714-815-01
11-digit product format 167140815
Labeler code 16714
Product ID 16714-815_a5fc36d0-2569-52dd-e053-2a95a90a3dbf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zoledronic acid
Dosage form INJECTION
Route INTRAVENOUS
Labeler Northstar RxLLC
Application ANDA205279
Marketing category ANDA
Marketing start 2018-05-30
Marketing end 0000-00-00
Substance ZOLEDRONIC ACID
Active strength 4 mg/5mL
Pharmacologic classes Diphosphonates [CS],Bisphosphonate [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 16714-815 16714-815-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A205279-001 ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205279-001 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 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205279-001 ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE / INTRAVENOUS AP 2016-11-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-815 ZOLEDRONIC ACID INJECTION [NORTHSTAR RXLLC] 4 Legacy NDC 20240718_1349fb63-3d9d-4dc0-bdbb-5af0429f9a72.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-815-01 16714081501 1 VIAL in 1 CARTON (16714-815-01) > 5 mL in 1 VIAL 1 vial 2018-05-30 0000-00-00 No No Current