FDA.reportPublic FDA data

Midodrine Hydrochloride

Product NDC
82293-004
11-digit product format
822930004
Labeler code
82293
Product ID
82293-004_451b5336-7460-7ffc-e063-6294a90aa15b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midodrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Novugen Pharma (USA) LLC
Application
ANDA211973
Marketing category
ANDA
Marketing start
2023-10-18
Substance
MIDODRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211973-001MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-10-17
A211973-002MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2023-10-17
A211973-003MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2023-10-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211973-001AB
A211973-002AB
A211973-003AB

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 22:54:322026-06A211973-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-10-17a50c72e98297…
2026-08-01 22:54:322026-06A211973-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2023-10-17a50c72e98297…
2026-08-01 22:54:322026-06A211973-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2023-10-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211973-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211973-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A211973-003AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDENovugen Pharma (USA) LLC2bf011fe-d114-42a4-93e2-76a993a3ba342025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211973
application number: ANDA211973
ndc (product): 82293-004

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDODRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59JV96YTXVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993462Internal RxNorm lookup
993466Internal RxNorm lookup
993470Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2bf011fe-d114-42a4-93e2-76a993a3ba34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee08dc62-0af6-bb42-639c-6cdc4aad4b08Product name620250801

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82293-004-10Midodrine Hydrochloride100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-004-10EA - Each82293-004e533bb24-615f-430e-8708-78fa2e0c191c12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82293-004MIDODRINE HYDROCHLORIDE TABLET [NOVUGEN PHARMA (USA) LLC]2Current NDC, 1 package rows20240820_2bf011fe-d114-42a4-93e2-76a993a3ba34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSN2bf011fe-d114-42a4-93e2-76a993a3ba343
993466midodrine HCl 2.5 MG Oral TabletPSN2bf011fe-d114-42a4-93e2-76a993a3ba343
993470midodrine HCl 5 MG Oral TabletPSN2bf011fe-d114-42a4-93e2-76a993a3ba343
993462midodrine hydrochloride 10 MG Oral TabletSCD2bf011fe-d114-42a4-93e2-76a993a3ba343
993466midodrine hydrochloride 2.5 MG Oral TabletSCD2bf011fe-d114-42a4-93e2-76a993a3ba343
993470midodrine hydrochloride 5 MG Oral TabletSCD2bf011fe-d114-42a4-93e2-76a993a3ba343
993470midodrine HCl 5 MG Oral TabletPSN266e3c61-d047-c413-e063-6394a90a36111
993470midodrine hydrochloride 5 MG Oral TabletSCD266e3c61-d047-c413-e063-6394a90a36111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82293-004-1082293000410100 TABLET in 1 BOTTLE (82293-004-10) 100 tablet2023-10-18NoNoCurrent