Nifedipine

Product NDC
68682-106
11-digit product format
686820106
Labeler code
68682
Product ID
68682-106_2c9ac184-8e21-479c-a1e8-4abeadfb54a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA075269
Marketing category
ANDA
Marketing start
2000-12-04
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075269-001NIFEDIPINENIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04
A075269-002NIFEDIPINENIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075269-001AB1
A075269-002AB1

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075269-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A075269-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB12000-12-04782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075269-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075269-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075269-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075269-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075269-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075269-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075269-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075269-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075269-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075269-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075269-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075269-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075269-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075269-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075269-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075269-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075269-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075269-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075269-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075269-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075269-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075269-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075269-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075269-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075269-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075269-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075269-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075269-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075269-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075269-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075269-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075269-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075269-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075269-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075269-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075269-002AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075269-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075269-002AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075269-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A075269-002AB11782e0a99824c…

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198035Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb6d8f32-198e-4ccf-bf25-069c03d624fdAvailable 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
68682-106-10Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
68682-106-30Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE3007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-106-10EA - Each68682-106398460de-6169-42a7-8552-e890e5fe3bb612016-05-16
68682-106-30EA - Each68682-10617c185db-dbe8-4771-921d-2f61423fa5c312016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-106NIFEDIPINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20200114_fb6d8f32-198e-4ccf-bf25-069c03d624fd.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 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NifedipineNIFEDIPINEBryant Ranch Prepack59724871-b495-4911-a86d-20069ec42edd2026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
NifedipineNIFEDIPINEBryant Ranch Prepackcb9d013a-2303-4e1d-a539-8ff04d5ec91d2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
NifedipineNIFEDIPINEBryant Ranch Prepack0b4e9bbc-4c16-4611-9ea2-9038528042272026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
NifedipineNIFEDIPINEOceanside Pharmaceuticalsfb6d8f32-198e-4ccf-bf25-069c03d624fd2026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
ndc (product): 68682-106
NifedipineNIFEDIPINENorthwind Health Company, LLCd9dec600-4e11-8292-e053-2a95a90a68422026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
NifedipineNIFEDIPINEOceanside Pharmaceuticalscb051508-60f3-4b89-9da0-5261024bd7f42025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
NifedipineNIFEDIPINEAphena Pharma Solutions - Tennessee, LLC81e6c8e7-e826-4abb-ad58-1dee62091a662024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
NifedipineNIFEDIPINEA-S Medication Solutionsaf5a6330-1819-4724-9f08-da45ac9fb4782023-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269
NifedipineNIFEDIPINEAphena Pharma Solutions - Tennessee, LLC95a53fc5-852d-4892-af20-2aaece9399ba2018-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075269
application number: ANDA075269

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN0b4e9bbc-4c16-4611-9ea2-903852804227101
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD0b4e9bbc-4c16-4611-9ea2-903852804227101
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY0b4e9bbc-4c16-4611-9ea2-903852804227101
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSNfb6d8f32-198e-4ccf-bf25-069c03d624fd7
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCDfb6d8f32-198e-4ccf-bf25-069c03d624fd7
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSYfb6d8f32-198e-4ccf-bf25-069c03d624fd7
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN81e6c8e7-e826-4abb-ad58-1dee62091a664
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD81e6c8e7-e826-4abb-ad58-1dee62091a664
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY81e6c8e7-e826-4abb-ad58-1dee62091a664
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-106-1068682010610100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-106-10) 2000-12-040000-00-00NoNoCurrent
68682-106-3068682010630300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-106-30) 2000-12-040000-00-00NoNoCurrent