Home NDC 0054-0282 Alendronate Sodium
Product NDC 0054-0282
11-digit product format 000540282
Labeler code 0054
Product ID 0054-0282_56e063a8-8c3d-4445-91fd-0c8806c2b127
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alendronate Sodium
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA090520
Marketing category ANDA
Marketing start 2020-10-30
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 A090520-001 ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090520-001 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.
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 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 0054-0282-59 Alendronate Sodium 75 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 75 4 0054-0282-59 Alendronate Sodium 4 in 1 CARTON SOLUTION 4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0282 ALENDRONATE SODIUM SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20201030_c910bb05-279b-4ffa-a867-46f4a0853ed5.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 Marketing end Sample Exclude flag Status 0054-0282-59 00054028259 4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE 2020-10-30 0000-00-00 No No Current