FDA.reportPublic FDA data

Application 074928

Type
ANDA
Sponsor
EPIC PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL20MGNoNo
002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL30MGNoNo

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
A074928-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19
A074928-002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074928-001AB
A074928-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19a50c72e98297…
2026-08-01 22:54:322026-06A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074928-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A074928-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEEpic Pharma, LLCb8f147b8-955f-4733-9178-2cfa0beb60d62023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074928
application number: ANDA074928
ndc (product): 42806-502
ndc (product): 42806-501
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEPuraCap Laboratories LLC dba Blu Pharmaceuticals065efabf-8c7d-4dd5-aef2-700c2eca399d2019-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074928
application number: ANDA074928
ndc (product): 24658-750
ndc (product): 24658-751

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24658-750Nicardipine HydrochlorideNicardipine HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-751Nicardipine HydrochlorideNicardipine HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
42806-501Nicardipine HydrochlorideNicardipine HydrochlorideEpic Pharma, LLCANDACurrent
42806-502Nicardipine HydrochlorideNicardipine HydrochlorideEpic Pharma, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22385ORIG1998-03-19
18373ORIG1998-03-19
8464ORIG1998-03-19