FDA.reportPublic FDA data

Metopirone

Product NDC
68118-455
11-digit product format
681180455
Labeler code
68118
Product ID
68118-455_522c880b-4112-b33c-e063-6294a90aa12a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metyrapone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
ESTEVE PHARMACEUTICALS, S.A.
Application
NDA012911
Marketing category
NDA
Marketing start
1962-01-25
Substance
METYRAPONE
Active strength
250 mg/1
Pharmacologic classes
Adrenal Steroid Synthesis Inhibitor [EPC], Adrenal Steroid Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metopirone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METYRAPONE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZS9KD92H6V
Rxcui105450, 199772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
05cc66c6-dbef-0902-b782-c1684bd46672Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68118-455-18Metopirone18 in 1 BOTTLECAPSULE, GELATIN COATED183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105450Metopirone 250 MG Oral CapsulePSN4046b167-7a46-8f4a-e063-6394a90a147f3
199772metyraPONE 250 MG Oral CapsulePSN4046b167-7a46-8f4a-e063-6394a90a147f3
105450metyrapone 250 MG Oral Capsule [Metopirone]SBD4046b167-7a46-8f4a-e063-6394a90a147f3
199772metyrapone 250 MG Oral CapsuleSCD4046b167-7a46-8f4a-e063-6394a90a147f3
105450Metopirone 250 MG Oral CapsuleSY4046b167-7a46-8f4a-e063-6394a90a147f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68118-455-186811804551818 CAPSULE, GELATIN COATED in 1 BOTTLE (68118-455-18) 1962-01-25NoNoCurrent