FDA.reportPublic FDA data

Nifedipine

Product NDC
71205-965
11-digit product format
712050965
Labeler code
71205
Product ID
71205-965_ba67d6b0-f638-4264-9bd4-1557223abe83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203126
Marketing category
ANDA
Marketing start
2014-11-01
Substance
NIFEDIPINE
Active strength
90 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE90 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
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
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
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
71205-965-00Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
71205-965-30Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE303
71205-965-60Nifedipine60 in 1 BOTTLETABLET, EXTENDED RELEASE603
71205-965-64Nifedipine240 in 1 BOTTLETABLET, EXTENDED RELEASE2403
71205-965-67Nifedipine270 in 1 BOTTLETABLET, EXTENDED RELEASE2703
71205-965-72Nifedipine120 in 1 BOTTLETABLET, EXTENDED RELEASE1203
71205-965-78Nifedipine180 in 1 BOTTLETABLET, EXTENDED RELEASE1803
71205-965-90Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE903
71205-965-96Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE3003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-965-00EA - Each71205-96540bd8c81-e9dd-4ba8-89ea-8b1945b3e69212021-06-02
71205-965-30EA - Each71205-96555bfa073-70ad-445b-a52c-42daf53841de12021-06-02
71205-965-60EA - Each71205-96546d259a7-0a4c-441d-a5d7-a96b20b0d1fa12021-06-02
71205-965-64EA - Each71205-965d808ec33-4898-4b9b-aeba-4e77660f9c9412021-06-02
71205-965-67EA - Each71205-965d50eb5df-e46e-45c0-aa14-720c44f1c47c12021-06-02
71205-965-72EA - Each71205-96529a8b69b-6d8c-4625-b16d-3a6beda514b512021-06-02
71205-965-78EA - Each71205-9651e183b52-bfd7-41bd-afea-917171ebaf0012021-06-02
71205-965-90EA - Each71205-96505bc52e6-fba0-4b47-845b-8e33b4edeadc12021-06-02
71205-965-96EA - Each71205-965f8a5fa5b-f827-4ed3-b580-90de1c5bbd8f12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-965NIFEDIPINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 9 package rows20220331_d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-965-0071205096500100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-00) 2020-06-090000-00-00NoNoCurrent
71205-965-307120509653030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-30) 2020-10-060000-00-00NoNoCurrent
71205-965-607120509656060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-60) 2020-10-060000-00-00NoNoCurrent
71205-965-6471205096564240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-64) 2020-10-060000-00-00NoNoCurrent
71205-965-6771205096567270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-67) 2020-10-060000-00-00NoNoCurrent
71205-965-7271205096572120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-72) 2020-10-060000-00-00NoNoCurrent
71205-965-7871205096578180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-78) 2020-10-060000-00-00NoNoCurrent
71205-965-907120509659090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-90) 2020-10-060000-00-00NoNoCurrent
71205-965-9671205096596300 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-965-96) 2020-06-090000-00-00NoNoCurrent