Home NDC 69452-353 Acamprosate Calcium
Product NDC 69452-353
11-digit product format 694520353
Labeler code 69452
Product ID 69452-353_44732224-b730-9a24-e063-6394a90ac0c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acamprosate Calcium
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Bionpharma Inc.,
Application ANDA219904
Marketing category ANDA
Marketing start 2025-12-01
Substance ACAMPROSATE CALCIUM
Active strength 333 mg/1
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 A219904-001 ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE / ORAL AB 2025-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219904-001 AB
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 A219904-001 ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE / ORAL AB 2025-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219904-001 ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE / ORAL AB 2025-09-18 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219904-001 ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE / ORAL AB 2025-09-18 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219904-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219904-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219904-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Acamprosate Calcium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACAMPROSATE CALCIUM 333 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 59375N1D0U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835726 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 69452-353-25 Acamprosate Calcium 180 in 1 BOTTLE TABLET, DELAYED RELEASE 180 1
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 69452-353-25 69452035325 180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25) 2025-12-01 No No Current