FDA.reportPublic FDA data

Metopirone

Product NDC
76336-455
11-digit product format
763360455
Labeler code
76336
Product ID
76336-455_47d0c075-05db-df45-e063-6294a90a4e12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metyrapone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
HRA Pharma Rare Diseases
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
76336-455-18Metopirone18 in 1 BOTTLECAPSULE, GELATIN COATED1819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76336-455-17EA - Each76336-45539ccd362-4b3f-464d-a41b-2726ecd4088212012-07-24
76336-455-18EA - Each76336-455e3ea77f8-7933-489b-80f4-91a2bfd19c9912014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METYRAPONEACTIVE INGREDIENTZS9KD92H6VMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1
METYRAPONEACTIVE MOIETYZS9KD92H6VMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1
ETHYL VANILLININACTIVE INGREDIENTYC9ST449YJMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1
GELATININACTIVE INGREDIENT2G86QN327LMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76336-455METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [HRA PHARMA RARE DISEASES]16Current NDC, Legacy NDC, 1 package rows20250201_3a27d0ef-83a7-4e1c-9430-46a3326ee8d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105450Metopirone 250 MG Oral CapsulePSN3a27d0ef-83a7-4e1c-9430-46a3326ee8d819
199772metyraPONE 250 MG Oral CapsulePSN3a27d0ef-83a7-4e1c-9430-46a3326ee8d819
105450metyrapone 250 MG Oral Capsule [Metopirone]SBD3a27d0ef-83a7-4e1c-9430-46a3326ee8d819
199772metyrapone 250 MG Oral CapsuleSCD3a27d0ef-83a7-4e1c-9430-46a3326ee8d819
105450Metopirone 250 MG Oral CapsuleSY3a27d0ef-83a7-4e1c-9430-46a3326ee8d819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76336-455-187633604551818 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18) 1962-01-250000-00-00NoNoCurrent