FDA.reportPublic FDA data

ACTONEL

Product NDC
0149-0471
11-digit product format
001490471
Labeler code
0149
Product ID
0149-0471_05985725-417c-44f4-9e38-4fed7cdfdaad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISEDRONATE SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Warner Chilcott Pharmaceuticals Inc.
Application
NDA020835
Marketing category
NDA
Marketing start
2000-04-14
Marketing end
0000-00-00
Substance
RISEDRONATE SODIUM
Active strength
5 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0149-0471-012021-01-07C16284748780-1956f9ecf-bf97-621f-e053-dbdaa90a74ad563c6d6d-56df-43a7-a7aa-709c5ea3cdbe
0149-0471-032021-01-07C16284748780-1956f9ecf-bf97-621f-e053-dbdaa90a74ad563c6d6d-56df-43a7-a7aa-709c5ea3cdbe
0149-0471-012019-10-21C16284748780-1956f9ecf-bf97-621f-e053-dbdaa90a74ad563c6d6d-56df-43a7-a7aa-709c5ea3cdbe
0149-0471-032019-10-21C16284748780-1956f9ecf-bf97-621f-e053-dbdaa90a74ad563c6d6d-56df-43a7-a7aa-709c5ea3cdbe

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISEDRONATE SODIUMACTIVE INGREDIENTOFG5EXG60LACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
RISEDRONIC ACIDACTIVE MOIETYKM2Z91756ZACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905093{4 (risedronate sodium 35 MG Oral Tablet [Actonel]) } Pack [Actonel 35 4-Week]BPCK4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905092{4 (risedronate sodium 35 MG Oral Tablet) } PackGPCK4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905030Actonel 150 MG Oral TabletPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905093Actonel 35 4-Week Once Weekly DosepackPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905026Actonel 35 MG Oral TabletPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905043Actonel 5 MG Oral TabletPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905028risedronate sodium 150 MG Oral TabletPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905092risedronate sodium 35 MG (4) Oral Tablet PackPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905024risedronate sodium 35 MG Oral TabletPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905041risedronate sodium 5 MG Oral TabletPSN4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905030risedronate sodium 150 MG Oral Tablet [Actonel]SBD4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905026risedronate sodium 35 MG Oral Tablet [Actonel]SBD4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905043risedronate sodium 5 MG Oral Tablet [Actonel]SBD4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905028risedronate sodium 150 MG Oral TabletSCD4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905024risedronate sodium 35 MG Oral TabletSCD4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905041risedronate sodium 5 MG Oral TabletSCD4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905030Actonel 150 MG Oral TabletSY4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905093Actonel 35 4-Week Once Weekly DosepackSY4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905026Actonel 35 MG Oral TabletSY4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905043Actonel 5 MG Oral TabletSY4423d70a-b120-4653-bcf3-0c5ea8b97b0e2
905092risedronate sodium 35 MG Oral Tablet, 4 Week PackSY4423d70a-b120-4653-bcf3-0c5ea8b97b0e2