Home NDC 70954-264 Alendronate Sodium
Product NDC 70954-264
11-digit product format 709540264
Labeler code 70954
Product ID 70954-264_844cce5a-3714-4394-be02-a25a6255330a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alendronate Sodium
Dosage form SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA214512
Marketing category ANDA
Marketing start 2023-05-24
Substance ALENDRONATE SODIUM
Active strength 70 mg/75mL
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 A214512-001 ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214512-001 AA
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 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214512-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA 2023-05-11 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A214512-001 CGT 2023-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214512-001 CGT 2023-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214512-001 CGT 2023-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214512-001 CGT 2023-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214512-001 CGT 2023-11-20 3f0d92c62455…
Additional Listing Data#
Finished product Yes
Brand name base Alendronate Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALENDRONATE SODIUM 70 mg/75mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2UY4M2U3RA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904447 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 70954-264-10 Alendronate Sodium 75 mL in 1 BOTTLE SOLUTION 75 2 70954-264-10 Alendronate Sodium 4 in 1 CARTON SOLUTION 4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-264 ALENDRONATE SODIUM SOLUTION [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20230525_81589178-10c9-4806-91eb-54e638d35b8d.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 Sample Exclude flag Status 70954-264-10 70954026410 4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLE 4 bottle 2023-05-24 No No Current