MIDODRINE HYDROCHLORIDE

Product NDC
0115-4233
11-digit product format
001154233
Labeler code
0115
Product ID
0115-4233_6adc2229-0675-45c0-b10d-10565489b80e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDODRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Impax Generics
Application
ANDA076449
Marketing category
ANDA
Marketing start
2005-12-16
Marketing end
0000-00-00
Substance
MIDODRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-4233-01MIDODRINE HYDROCHLORIDE100 in 1 BOTTLETABLET1007
0115-4233-02MIDODRINE HYDROCHLORIDE500 in 1 BOTTLETABLET5007
0115-4233-03MIDODRINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-4233-01EA - Each0115-4233c2d88e26-23aa-4abc-9ad6-fc8498477dee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDODRINE HYDROCHLORIDEACTIVE INGREDIENT59JV96YTXVMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
MIDODRINEACTIVE MOIETY6YE7PBM15HMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UMIDODRINE HYDROCHLORIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-4233MIDODRINE HYDROCHLORIDE TABLET [IMPAX GENERICS]7Legacy NDC, 3 package rows20170605_e2e3db6b-054a-4f63-9936-482663c6395a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSNe2e3db6b-054a-4f63-9936-482663c6395a7
993466midodrine HCl 2.5 MG Oral TabletPSNe2e3db6b-054a-4f63-9936-482663c6395a7
993470midodrine HCl 5 MG Oral TabletPSNe2e3db6b-054a-4f63-9936-482663c6395a7
993462midodrine hydrochloride 10 MG Oral TabletSCDe2e3db6b-054a-4f63-9936-482663c6395a7
993466midodrine hydrochloride 2.5 MG Oral TabletSCDe2e3db6b-054a-4f63-9936-482663c6395a7
993470midodrine hydrochloride 5 MG Oral TabletSCDe2e3db6b-054a-4f63-9936-482663c6395a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0115-4233-0100115423301100 in 1 BOTTLEHistorical
0115-4233-0200115423302500 in 1 BOTTLEHistorical
0115-4233-03001154233031000 in 1 BOTTLEHistorical