FDA.reportPublic FDA data

Atelvia

Product NDC
0430-0979
11-digit product format
004300979
Labeler code
0430
Product ID
0430-0979_936662af-4e07-4361-b7ef-760ebfad3e01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risedronate sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA022560
Marketing category
NDA
Marketing start
2010-12-01
Substance
RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength
30.1; 4.9 mg/1; mg/1
Pharmacologic classes
Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atelvia
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISEDRONATE SODIUM HEMIPENTAHYDRATE30.1 mg/1
RISEDRONATE SODIUM MONOHYDRATE4.9 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHU2YAQ274O, F67L43UT5C
Rxcui1020064, 1020065, 1020066

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc99ed49-98e9-42a6-aef0-a6dc585a6a09Product name420191002
a51ae56f-109a-47a0-9ce1-2b825be8c01bProduct name520190614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0430-0979-03Atelvia4 in 1 DOSE PACKTABLET, DELAYED RELEASE429

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0430-0979-03EA - Each0430-09794f8e2f3d-ce56-4485-b7ee-30a28901e64212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISEDRONATE SODIUM HEMI-PENTAHYDRATEACTIVE INGREDIENTHU2YAQ274OATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
RISEDRONATE SODIUM MONOHYDRATEACTIVE INGREDIENTF67L43UT5CATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
RISEDRONIC ACIDACTIVE MOIETYKM2Z91756ZATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
TALCINACTIVE INGREDIENT7SEV7J4R1UATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0430-0979ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [ALLERGAN, INC.]24Current NDC, Legacy NDC, 1 package rows20240913_c8b9ab88-1a26-46c3-80ec-4eaa45202021.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020066{4 (risedronate sodium 35 MG Delayed Release Oral Tablet) } Pack [Atelvia]BPCKc8b9ab88-1a26-46c3-80ec-4eaa4520202129
1020065{4 (risedronate sodium 35 MG Delayed Release Oral Tablet) } PackGPCKc8b9ab88-1a26-46c3-80ec-4eaa4520202129
1020066Atelvia 35 MG Delayed Release Oral Tablet Once-a-Week PackPSNc8b9ab88-1a26-46c3-80ec-4eaa4520202129
1020064risedronate sodium 35 MG Delayed Release Oral TabletPSNc8b9ab88-1a26-46c3-80ec-4eaa4520202129
1020065risedronate sodium 35 MG Delayed Release Oral Tablet 4 Count PackPSNc8b9ab88-1a26-46c3-80ec-4eaa4520202129
1020064risedronate sodium 35 MG Delayed Release Oral TabletSCDc8b9ab88-1a26-46c3-80ec-4eaa4520202129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0430-0979-03004300979034 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03) 2010-12-010000-00-00NoNoCurrent