FDA.reportPublic FDA data

acamprosate calcium

Product NDC
70771-1057
11-digit product format
707711057
Labeler code
70771
Product ID
70771-1057_c9752e78-2bf3-4e62-a947-a3d7fe757a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acamprosate calcium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205995
Marketing category
ANDA
Marketing start
2017-06-01
Substance
ACAMPROSATE CALCIUM
Active strength
333 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acamprosate calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACAMPROSATE CALCIUM333 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii59375N1D0U
Rxcui835726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c95d5956-8a83-9dba-bb9d-d7b5fb3324ecProduct name320170724
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1057-0acamprosate calcium1000 in 1 BOTTLETABLET, DELAYED RELEASE10004
70771-1057-1acamprosate calcium100 in 1 BOTTLETABLET, DELAYED RELEASE1004
70771-1057-3acamprosate calcium30 in 1 BOTTLETABLET, DELAYED RELEASE304
70771-1057-5acamprosate calcium500 in 1 BOTTLETABLET, DELAYED RELEASE5004
70771-1057-8acamprosate calcium180 in 1 BOTTLETABLET, DELAYED RELEASE1804
70771-1057-9acamprosate calcium90 in 1 BOTTLETABLET, DELAYED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1057ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 6 package rows20231107_0c729939-d2d2-4e61-acbc-4f1646dc38c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSN0c729939-d2d2-4e61-acbc-4f1646dc38c14
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCD0c729939-d2d2-4e61-acbc-4f1646dc38c14
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSY0c729939-d2d2-4e61-acbc-4f1646dc38c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1057-0707711057001000 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-0) 2017-06-010000-00-00NoNoCurrent
70771-1057-170771105701100 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-1) 2017-06-010000-00-00NoNoCurrent
70771-1057-37077110570330 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-3) 2017-06-010000-00-00NoNoCurrent
70771-1057-570771105705500 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-5) 2017-06-010000-00-00NoNoCurrent
70771-1057-870771105708180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-8) 2017-06-010000-00-00NoNoCurrent
70771-1057-97077110570990 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-9) 2017-06-010000-00-00NoNoCurrent