FDA.reportPublic FDA data

Application 018655

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORPACE CRDISOPYRAMIDE PHOSPHATECAPSULE, EXTENDED RELEASE;ORALEQ 100MG BASEYesNo
002NORPACE CRDISOPYRAMIDE PHOSPHATECAPSULE, EXTENDED RELEASE;ORALEQ 150MG BASEYesYes

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

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
N018655-001NORPACE CRDISOPYRAMIDE PHOSPHATEEQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20
N018655-002NORPACE CRDISOPYRAMIDE PHOSPHATEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20e64feba35796…
2022-09-29 23:25 UTC2022-09N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorpaceDISOPYRAMIDE PHOSPHATEPfizer Laboratories Div Pfizer Ince2aa1642-d262-4520-bc6a-9fd3ad7956772026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0025-2742
ndc (product): 0025-2732

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-2732Norpace CRdisopyramide phosphateG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-2732Norpace CRdisopyramide phosphateG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-2732Norpace CRdisopyramide phosphateG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-2732Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2732Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2732Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2732Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2732Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphateG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphateG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphateG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
0025-2742Norpace CRdisopyramide phosphatePfizer Laboratories Div Pfizer IncNDACurrent
68151-0526Norpacedisopyramide phosphateCarilion Materials ManagementNDACurrent
68151-0527Norpacedisopyramide phosphateCarilion Materials ManagementNDACurrent