DISOPYRAMIDE PHOSPHATE

Product NDC
51862-095
11-digit product format
518620095
Labeler code
51862
Product ID
51862-095_3dfeb589-b234-6c61-e063-6294a90a1deb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DISOPYRAMIDE PHOSPHATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Mayne Pharma Commercial LLC
Application
ANDA070173
Marketing category
ANDA
Marketing start
2022-04-01
Substance
DISOPYRAMIDE PHOSPHATE
Active strength
100 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DISOPYRAMIDE PHOSPHATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DISOPYRAMIDE PHOSPHATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN6BOM1935W
Rxcui309958, 309960

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d08b5e1c-4339-4b83-bd26-a59d84e2a782Product name120170614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-095-01DISOPYRAMIDE PHOSPHATE100 in 1 BOTTLECAPSULE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-095-01EA - Each51862-0959a21ef46-f989-448f-a3b6-87bde12dee2212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-095DISOPYRAMIDE PHOSPHATE CAPSULE [MAYNE PHARMA COMMERCIAL LLC]5Current NDC, Legacy NDC, 1 package rows20230707_7d550b12-065a-416c-93fa-b61368eeb36f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309958disopyramide phosphate 100 MG Oral CapsulePSN7d550b12-065a-416c-93fa-b61368eeb36f6
309960disopyramide phosphate 150 MG Oral CapsulePSN7d550b12-065a-416c-93fa-b61368eeb36f6
309958disopyramide 100 MG Oral CapsuleSCD7d550b12-065a-416c-93fa-b61368eeb36f6
309960disopyramide 150 MG Oral CapsuleSCD7d550b12-065a-416c-93fa-b61368eeb36f6
309958disopyramide 100 MG (as disopyramide phosphate) Oral CapsuleSY7d550b12-065a-416c-93fa-b61368eeb36f6
309960disopyramide 150 MG (as disopyramide phosphate) Oral CapsuleSY7d550b12-065a-416c-93fa-b61368eeb36f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-095-0151862009501100 CAPSULE in 1 BOTTLE (51862-095-01) 100 capsule2022-04-010000-00-00NoNoCurrent