Home NDC 0615-8660 Acamprosate Calcium
Product NDC 0615-8660
11-digit product format 006158660
Labeler code 0615
Product ID 0615-8660_d1900128-c353-4453-bbc2-854e9043edcc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acamprosate Calcium
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 A219904-001 ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE / ORAL AB 2025-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219904-001 ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE / ORAL AB 2025-09-18 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acamprosate Calcium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACAMPROSATE CALCIUM 333 mg/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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0615-8660-39 00615866039 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8660-39) 2026-09-15 No No Current