Nifedipine

Product NDC
23155-194
11-digit product format
231550194
Labeler code
23155
Product ID
23155-194_b9bbf7c7-2447-4cb1-a0c2-662a9d01d6d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202644
Marketing category
ANDA
Marketing start
2010-12-07
Substance
NIFEDIPINE
Active strength
10 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

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
A202644-001NIFEDIPINENIFEDIPINE10MGCAPSULE / ORALABRS2013-04-25
A202644-002NIFEDIPINENIFEDIPINE20MGCAPSULE / ORALAB2013-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202644-001AB
A202644-002AB

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 UTC2026-02A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202644-001NIFEDIPINE10MGCAPSULE / ORALAB2013-04-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A202644-002NIFEDIPINE20MGCAPSULE / ORALAB2013-04-25782e0a99824c…

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 UTC2026-02A202644-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202644-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202644-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202644-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202644-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202644-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202644-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202644-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202644-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202644-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202644-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202644-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202644-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202644-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202644-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202644-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202644-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202644-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202644-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202644-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202644-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202644-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202644-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202644-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202644-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202644-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202644-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202644-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202644-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202644-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202644-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202644-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202644-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202644-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202644-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202644-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202644-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202644-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202644-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202644-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE10 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198032Internal RxNorm lookup
198033Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8b8cfee-ea71-44c2-81af-675efecfdf15Available 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
23155-194-01Nifedipine100 in 1 BOTTLECAPSULE10017
23155-194-13Nifedipine300 in 1 BOTTLECAPSULE30017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-194-01EA - Each23155-19412bbb8b0-66b4-4eb4-b70d-bf0e824ae7a012013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
AMMONIAINACTIVE INGREDIENT5138Q19F1XNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-194NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20230804_b8b8cfee-ea71-44c2-81af-675efecfdf15.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NifedipineNIFEDIPINEMajor Pharmaceuticalsacb493a3-b8f2-41a9-8ab2-550d97c4592a2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202644
application number: ANDA202644
NifedipineNIFEDIPINEREMEDYREPACK INC.bddfd658-ac61-4ba2-a3fa-07acc35d368a2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202644
application number: ANDA202644
NifedipineNIFEDIPINECardinal Health 107, LLC472621b6-c2b7-4582-9ceb-7cead55ff2472026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202644
application number: ANDA202644
NifedipineNIFEDIPINEChartwell RX, LLC5014847e-389d-48c1-8350-b9b24ca8d2a42025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202644
application number: ANDA202644
NifedipineNIFEDIPINEPD-Rx Pharmaceuticals, Inc.51cdb22b-035f-47d7-8048-38006e2589f22025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202644
application number: ANDA202644
NifedipineNIFEDIPINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b8b8cfee-ea71-44c2-81af-675efecfdf152023-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202644
application number: ANDA202644
ndc (product): 23155-194

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN51cdb22b-035f-47d7-8048-38006e2589f221
198032nifedipine 10 MG Oral CapsuleSCD51cdb22b-035f-47d7-8048-38006e2589f221
198032NIFEdipine 10 MG Oral CapsulePSNb8b8cfee-ea71-44c2-81af-675efecfdf1517
198033NIFEdipine 20 MG Oral CapsulePSNb8b8cfee-ea71-44c2-81af-675efecfdf1517
198032nifedipine 10 MG Oral CapsuleSCDb8b8cfee-ea71-44c2-81af-675efecfdf1517
198033nifedipine 20 MG Oral CapsuleSCDb8b8cfee-ea71-44c2-81af-675efecfdf1517
198032NIFEdipine 10 MG Oral CapsulePSNacb493a3-b8f2-41a9-8ab2-550d97c4592a3
198032nifedipine 10 MG Oral CapsuleSCDacb493a3-b8f2-41a9-8ab2-550d97c4592a3
198032NIFEdipine 10 MG Oral CapsulePSNbddfd658-ac61-4ba2-a3fa-07acc35d368a1
198032nifedipine 10 MG Oral CapsuleSCDbddfd658-ac61-4ba2-a3fa-07acc35d368a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-194-0123155019401100 CAPSULE in 1 BOTTLE (23155-194-01) 100 capsule2010-12-070000-00-00NoNoCurrent
23155-194-1323155019413300 CAPSULE in 1 BOTTLE (23155-194-13) 300 capsule2010-12-070000-00-00NoNoCurrent