FDA.reportPublic FDA data

Nifedipine

Product NDC
24979-010
11-digit product format
249790010
Labeler code
24979
Product ID
24979-010_58c4c95e-4db0-47e2-afb9-36472e6fcefc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA203126
Marketing category
ANDA
Marketing start
2014-11-01
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
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
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-010-12Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE30015
24979-010-01Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-010-01EA - Each24979-010302d4220-e04a-473f-957b-a994e5d1684612015-01-05
24979-010-12EA - Each24979-010f7a5e93f-4594-4d91-bb7c-4682abfbb0e412015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]3
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-010NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 1 package rows20231202_160271a8-7922-2107-e054-00144ff88e88.zip
24979-010NIFEDIPINE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 1 package rows20231202_3bf4282f-b063-4d35-8ef0-6f48b98e9deb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN160271a8-7922-2107-e054-00144ff88e8815
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN160271a8-7922-2107-e054-00144ff88e8815
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN160271a8-7922-2107-e054-00144ff88e8815
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD160271a8-7922-2107-e054-00144ff88e8815
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD160271a8-7922-2107-e054-00144ff88e8815
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD160271a8-7922-2107-e054-00144ff88e8815
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY160271a8-7922-2107-e054-00144ff88e8815
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY160271a8-7922-2107-e054-00144ff88e8815
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY160271a8-7922-2107-e054-00144ff88e8815
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY3bf4282f-b063-4d35-8ef0-6f48b98e9deb13
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYa84be46e-bb0c-d59f-e053-2a95a90aabde8
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYd428aa4d-4cc0-4b1e-b9f6-40ae65a735d63
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN549c7037-957e-068b-e054-00144ff8d46c2
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD549c7037-957e-068b-e054-00144ff8d46c2
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY549c7037-957e-068b-e054-00144ff8d46c2
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN838d6e8f-37b0-48d3-b701-c4fa32a87b851
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD838d6e8f-37b0-48d3-b701-c4fa32a87b851
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY838d6e8f-37b0-48d3-b701-c4fa32a87b851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-010-0124979001001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-010-01) 2014-11-010000-00-00NoNoCurrent
24979-010-1224979001012300 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-010-12) 2015-05-150000-00-00NoNoCurrent