FDA.reportPublic FDA data

NDC 63629-2346-01 - Midodrine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-2346
Requested NDC
63629-2346-01
Package NDCs from labels
63629-2346-1, 63629-2346-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Midodrine Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-01-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2346-1Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2346MIDODRINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240112_df43f108-c89c-49e7-9c1a-77a0ce9b03b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2346-1EA - Each63629-234699031228-e605-47d8-ac59-e08c42135f5e12021-06-02

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 3 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepackdf43f108-c89c-49e7-9c1a-77a0ce9b03b52024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207849
ndc (package): 63629-2346-1
ndc (product): 63629-2346
ndc11 (package): 63629234601
rxcui: 993462
spl id: 8bfa3b96-7a9d-411c-b193-be6de1269691
spl set id: df43f108-c89c-49e7-9c1a-77a0ce9b03b5
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack7ec8fb86-18c4-4751-87e4-ca1e9e8850882024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207849
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDELifestar Pharma LLC99d4aa03-81f7-4b43-a7b4-4ecc5ad133042023-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993462
rxcui: 993466
rxcui: 993470
unii: 59JV96YTXV
Midodrine hydrochlorideMIDODRINE HYDROCHLORIDEZydus Lifesciences Limitedb4c4417e-d8fd-46c8-b82f-ffbc8f2017522023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993462
rxcui: 993466
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEGolden State Medical Supply, Inc.c4d0b757-bb6e-4df4-e053-2995a90a30422023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207849
rxcui: 993462
rxcui: 993466
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack17b24a0b-03e4-4b58-87ab-3d66fec302262023-10-06Warnings, Adverse reactionsExact identifier
rxcui: 993466
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack60d5a132-9cfc-48e2-aa71-1949aeb255c32023-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack5a6705af-bb72-4edb-863a-93a351bd6dba2023-02-27Warnings, Adverse reactionsExact identifier
rxcui: 993466
unii: 59JV96YTXV
MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Limited03b54024-2a26-4abe-bd8b-b66bb6781fa72023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993462
rxcui: 993466
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEMylan Pharmaceuticals Inc.32fad00b-7e7b-4d35-9e8b-fdc979fdb88e2022-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993462
rxcui: 993466
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEProficient Rx LP0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207849
rxcui: 993462
rxcui: 993466
rxcui: 993470
unii: 59JV96YTXV
MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.873c8e29-6961-4648-bfc8-f91c2086bd942021-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993462
rxcui: 993466
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack2be17e48-8258-4f29-914b-7f0fe9ace7a12020-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993470
unii: 59JV96YTXV
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEXiromed, LLCa4332a41-2a0a-a14a-9ce5-1465f39ff7252020-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207849
ndc (product): 70700-159
rxcui: 993462
rxcui: 993466
rxcui: 993470
spl id: 2214523a-41b1-3644-6e7c-abc4f8b0b5cc
spl set id: a4332a41-2a0a-a14a-9ce5-1465f39ff725
unii: 59JV96YTXV

Reported adverse events (FAERS/openFDA)#

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