Nifedipine

Product NDC
50742-262
11-digit product format
507420262
Labeler code
50742
Product ID
50742-262_2d798366-5fb6-4ea5-b1cc-663a0c3290b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210614-001NIFEDIPINENIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12
A210614-002NIFEDIPINENIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12
A210614-003NIFEDIPINENIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB2RS2019-03-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A210614-001AB2
A210614-002AB2
A210614-003AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12c2088c7a36db…
2026-10-15 13:18:302026-09A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12c2088c7a36db…
2026-10-15 13:18:302026-09A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB2RS2019-03-12c2088c7a36db…
2026-09-14 22:38:342026-08A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1284e616aacf4f…
2026-09-14 22:38:342026-08A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1284e616aacf4f…
2026-09-14 22:38:342026-08A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB2RS2019-03-1284e616aacf4f…
2026-08-18 06:07:402026-07A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB2RS2019-03-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1279d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A210614-001AB21c2088c7a36db…
2026-10-15 13:18:302026-09A210614-002AB21c2088c7a36db…
2026-10-15 13:18:302026-09A210614-003AB21c2088c7a36db…
2026-09-14 22:38:342026-08A210614-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A210614-002AB2184e616aacf4f…
2026-09-14 22:38:342026-08A210614-003AB2184e616aacf4f…
2026-08-18 06:07:402026-07A210614-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A210614-002AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A210614-003AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210614-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210614-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210614-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-001AB2179d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE90 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I9ZF7L6G2LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1812011Internal RxNorm lookup
1812013Internal RxNorm lookup
1812015Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d3e11d2-d320-45d3-96c8-48322202b504Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50742-262-01Nifedipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
50742-262-03Nifedipine300 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3006
50742-262-30Nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-262-01EA - Each50742-262cd19fc57-e2b9-4114-8964-bd7f7032ca2512019-04-11
50742-262-03EA - Each50742-262f3dd60e5-b511-48a9-a8c3-85f22275fc8c12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-262NIFEDIPINE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 3 package rows20230207_4d3e11d2-d320-45d3-96c8-48322202b504.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NifedipineNIFEDIPINEBryant Ranch Prepack71a4e00b-8386-4da1-8515-a0e7e8db104d2023-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN4d3e11d2-d320-45d3-96c8-48322202b5046
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN4d3e11d2-d320-45d3-96c8-48322202b5046
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN4d3e11d2-d320-45d3-96c8-48322202b5046
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD4d3e11d2-d320-45d3-96c8-48322202b5046
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD4d3e11d2-d320-45d3-96c8-48322202b5046
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD4d3e11d2-d320-45d3-96c8-48322202b5046
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY4d3e11d2-d320-45d3-96c8-48322202b5046
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY4d3e11d2-d320-45d3-96c8-48322202b5046
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY4d3e11d2-d320-45d3-96c8-48322202b5046
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN1add684f-d082-72cc-e063-6394a90a12142
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD1add684f-d082-72cc-e063-6394a90a12142
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY1add684f-d082-72cc-e063-6394a90a12142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-262-0150742026201100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-262-01) 2019-03-120000-00-00NoNoCurrent
50742-262-0350742026203300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-262-03) 2019-03-120000-00-00NoNoCurrent
50742-262-305074202623030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-262-30) 2019-03-120000-00-00NoNoCurrent