FDA.reportPublic FDA data

Actonel

Product NDC
0430-0471
11-digit product format
004300471
Labeler code
0430
Product ID
0430-0471_68886216-39e0-4109-889b-1909995c71f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risedronate Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA020835
Marketing category
NDA
Marketing start
2000-04-14
Marketing end
0000-00-00
Substance
RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength
4 mg/1; mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
0430-0471-15Actonel30 in 1 BOTTLETABLET, FILM COATED3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0430-0471-15EA - Each0430-047167b2bf60-a0c5-423b-8a80-4ea1c94487d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISEDRONATE SODIUM HEMI-PENTAHYDRATEACTIVE INGREDIENTHU2YAQ274OACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
RISEDRONATE SODIUM MONOHYDRATEACTIVE INGREDIENTF67L43UT5CACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
RISEDRONIC ACIDACTIVE MOIETYKM2Z91756ZACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0430-0471ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [ALLERGAN, INC.]27Legacy NDC, 1 package rows20240912_24ed00e0-25e2-49a8-97fc-66c1b417dc0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905101{12 (risedronate sodium 35 MG Oral Tablet [Actonel]) } Pack [Actonel 35 12-Week]BPCK24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905087{2 (risedronate sodium 75 MG Oral Tablet [Actonel]) } Pack [Actonel 75]BPCK24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905093{4 (risedronate sodium 35 MG Oral Tablet [Actonel]) } Pack [Actonel 35 4-Week]BPCK24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905100{12 (risedronate sodium 35 MG Oral Tablet) } PackGPCK24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905084{2 (risedronate sodium 75 MG Oral Tablet) } PackGPCK24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905092{4 (risedronate sodium 35 MG Oral Tablet) } PackGPCK24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905030Actonel 150 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905034Actonel 30 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905101Actonel 35 12-Week Once Weekly DosepackPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905093Actonel 35 4-Week Once Weekly DosepackPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905026Actonel 35 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905043Actonel 5 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905087Actonel 75 DosepackPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905086Actonel 75 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905028risedronate sodium 150 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905032risedronate sodium 30 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905100risedronate sodium 35 MG (12) Oral Tablet PackPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905092risedronate sodium 35 MG (4) Oral Tablet PackPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905024risedronate sodium 35 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905041risedronate sodium 5 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905083risedronate sodium 75 MG Oral TabletPSN24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905030risedronate sodium 150 MG Oral Tablet [Actonel]SBD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905034risedronate sodium 30 MG Oral Tablet [Actonel]SBD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905026risedronate sodium 35 MG Oral Tablet [Actonel]SBD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905043risedronate sodium 5 MG Oral Tablet [Actonel]SBD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905086risedronate sodium 75 MG Oral Tablet [Actonel]SBD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905028risedronate sodium 150 MG Oral TabletSCD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905032risedronate sodium 30 MG Oral TabletSCD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905024risedronate sodium 35 MG Oral TabletSCD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905041risedronate sodium 5 MG Oral TabletSCD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905083risedronate sodium 75 MG Oral TabletSCD24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905030Actonel 150 MG Oral TabletSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905034Actonel 30 MG Oral TabletSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905101Actonel 35 12-Week Once Weekly DosepackSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905093Actonel 35 4-Week Once Weekly DosepackSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905026Actonel 35 MG Oral TabletSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905043Actonel 5 MG Oral TabletSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905087Actonel 75 DosepackSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905086Actonel 75 MG Oral TabletSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905084Risedronate 75 MG Oral Tablet 2 Count PackSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905100risedronate sodium 35 MG Oral Tablet, 12 Week PackSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31
905092risedronate sodium 35 MG Oral Tablet, 4 Week PackSY24ed00e0-25e2-49a8-97fc-66c1b417dc0b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0430-0471-150043004711530 in 1 BOTTLEHistorical