Nifedipine

Product NDC
51655-593
Requested package NDC
51655-593-26
11-digit product format
516550593
Labeler code
51655
Product ID
51655-593_494efb4b-e4f9-e991-e063-6294a90a7af8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA210614
Marketing category
ANDA
Marketing start
2023-01-03
Substance
NIFEDIPINE
Active strength
30 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 · 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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210614-001NIFEDIPINE30MGTABLET, 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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210614-001AB218072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE30 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
1812011Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f32c0fc9-b4ad-6a1f-e053-2995a90acf61Available on FDA.report

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
51655-593-26Nifedipine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-593NIFEDIPINE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240725_f32c0fc9-b4ad-6a1f-e053-2995a90acf61.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NifedipineNIFEDIPINESt. Mary's Medical Park Pharmacy1add684f-d082-72cc-e063-6394a90a12142026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINESt. Mary's Medical Park Pharmacy1ab8945b-bea5-9827-e063-6294a90af3342026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEBryant Ranch Prepacke1cd5011-b80e-4b1b-8729-56260b8b3c262026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINECoupler LLC518d39af-0be1-acbc-e063-6294a90a4ada2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEMajor Pharmaceuticals41aa6fbd-96c1-40f7-92d4-cfdd2d5325e92026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEIngenus Pharmaceuticals, LLC4d3e11d2-d320-45d3-96c8-48322202b5042026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINECardinal Health 107, LLCc98ecf77-ae9a-438b-9bad-ffbed25d95bc2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEA-S Medication Solutions446505e8-cd68-4037-bebe-954a893dc67b2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEA-S Medication Solutions3334ab6f-aeb0-4b78-8d17-f0aedd94f9962026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEREMEDYREPACK INC.24e56333-5601-48fd-a263-f6be90983fb42026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINENorthwind Health Company, LLCf8358be1-848c-d9eb-e053-6294a90a178c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINENorthwind Health Company, LLCf2f3564a-d43a-6c36-e053-2a95a90ae8782026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINENorthwind Health Company, LLCf32c0fc9-b4ad-6a1f-e053-2995a90acf612026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (package): 51655-593-26
ndc (product): 51655-593
ndc11 (package): 51655059326
NifedipineNIFEDIPINEA-S Medication Solutions9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd442025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEPreferred Pharmaceuticals Inc.cda16a27-f029-40a6-a0e8-2bed0de711692025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEPreferred Pharmaceuticals, Inc.4ee466dc-5a4e-4c77-8e94-8b510cafd61b2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEREMEDYREPACK INC.832fc274-605a-4b04-b327-dbf3611316212025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEBryant Ranch Prepack325acf27-4b2e-40e8-8344-bb6cc99599102025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINENuCare Pharmaceuticals,Inc.d5df10bc-16ed-7a97-e053-2a95a90ab15e2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINENCS HealthCare of KY, LLC dba Vangard Labs0cabe053-3b7e-4dcb-8441-ef7821bb6f682024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNf32c0fc9-b4ad-6a1f-e053-2995a90acf613
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDf32c0fc9-b4ad-6a1f-e053-2995a90acf613
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYf32c0fc9-b4ad-6a1f-e053-2995a90acf613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-593-265165505932690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-593-26) 2023-01-03NoNoCurrent