FDA.reportPublic FDA data

Nifedipine

Product NDC
50268-598
11-digit product format
502680598
Labeler code
50268
Product ID
50268-598_47e7d21f-e346-6413-e063-6294a90aa9be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA077127
Marketing category
ANDA
Marketing start
2011-02-11
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Brand name suffix
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812011, 1812013, 1812015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-598-11NifedipineER1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE116
50268-598-15NifedipineER50 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-598-11EA - Each50268-598b9006cbf-2ebe-43ea-9d51-ca5cc409017012015-05-05
50268-598-15EA - Each50268-59821dd06ff-054a-42cd-a755-beb5e3aaf21012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NifedipineACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
NifedipineACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Cellulose AcetateINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
HypromellosesINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Magnesium StearateINACTIVE INGREDIENT70097M6I30NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
PovidoneINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
TriacetinINACTIVE INGREDIENTXHX3C3X673NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-598NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]15Current NDC, Legacy NDC, 2 package rows20220119_d1a78ff2-7672-3e69-00ef-63d203c80484.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNd1a78ff2-7672-3e69-00ef-63d203c8048416
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNd1a78ff2-7672-3e69-00ef-63d203c8048416
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNd1a78ff2-7672-3e69-00ef-63d203c8048416
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDd1a78ff2-7672-3e69-00ef-63d203c8048416
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDd1a78ff2-7672-3e69-00ef-63d203c8048416
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDd1a78ff2-7672-3e69-00ef-63d203c8048416
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYd1a78ff2-7672-3e69-00ef-63d203c8048416
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYd1a78ff2-7672-3e69-00ef-63d203c8048416
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYd1a78ff2-7672-3e69-00ef-63d203c8048416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-598-11502680598111 in 1 BLISTER PACKHistorical
50268-598-155026805981550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-598-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-598-11) 50 blister pack2011-02-110000-00-00NoNoCurrent