FDA.reportPublic FDA data

acamprosate calcium

Product NDC
68382-569
11-digit product format
683820569
Labeler code
68382
Product ID
68382-569_2e5f04a0-3e2d-494f-837b-18570b6a8546
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acamprosate calcium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
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
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
68382-569-01acamprosate calcium100 in 1 BOTTLETABLET, DELAYED RELEASE1004
68382-569-05acamprosate calcium500 in 1 BOTTLETABLET, DELAYED RELEASE5004
68382-569-06acamprosate calcium30 in 1 BOTTLETABLET, DELAYED RELEASE304
68382-569-10acamprosate calcium1000 in 1 BOTTLETABLET, DELAYED RELEASE10004
68382-569-16acamprosate calcium90 in 1 BOTTLETABLET, DELAYED RELEASE904
68382-569-28acamprosate calcium180 in 1 BOTTLETABLET, DELAYED RELEASE1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-569-28EA - Each68382-56963e80f11-e81f-4641-967d-daf3fbae798112017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-569ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 6 package rows20231107_9803db35-2600-4f42-80c1-43216fd1ba3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSN9803db35-2600-4f42-80c1-43216fd1ba3d4
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCD9803db35-2600-4f42-80c1-43216fd1ba3d4
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSY9803db35-2600-4f42-80c1-43216fd1ba3d4
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSN91769a96-3182-4e38-90c3-b22c1beae3981
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCD91769a96-3182-4e38-90c3-b22c1beae3981
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSY91769a96-3182-4e38-90c3-b22c1beae3981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-569-0168382056901100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01) 2017-06-010000-00-00NoNoCurrent
68382-569-0568382056905500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05) 2017-06-010000-00-00NoNoCurrent
68382-569-066838205690630 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-06) 2017-06-010000-00-00NoNoCurrent
68382-569-10683820569101000 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-10) 2017-06-010000-00-00NoNoCurrent
68382-569-166838205691690 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-16) 2017-06-010000-00-00NoNoCurrent
68382-569-2868382056928180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-28) 2017-06-010000-00-00NoNoCurrent