Home NDC 71288-806 Zoledronic Acid
Product NDC 71288-806
11-digit product format 712880806
Labeler code 71288
Product ID 71288-806_a4589df5-8c10-4040-ba54-637c518a0e11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zoledronic Acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA213371
Marketing category ANDA
Marketing start 2023-06-05
Substance ZOLEDRONIC ACID
Active strength 5 mg/100mL
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 A213371-001 ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213371-001 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 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213371-001 ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE / INTRAVENOUS AP 2023-06-05 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 71288-806-51 Zoledronic Acid 100 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 100 1 71288-806-51 Zoledronic Acid 1 in 1 CARTON INJECTION, SOLUTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-806 ZOLEDRONIC ACID INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20230613_8aac81ae-f92c-4f0b-b480-44badf72b5f5.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 Marketing start Sample Exclude flag Status 71288-806-51 71288080651 1 BOTTLE, GLASS in 1 CARTON (71288-806-51) / 100 mL in 1 BOTTLE, GLASS 2023-06-05 No No Current