Home NDC 76336-455-18 Metopirone
Product NDC 76336-455
Requested package NDC 76336-455-18
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012911-001 METOPIRONE METYRAPONE 250MG TABLET / ORAL Approved before 1982 N012911-002 METOPIRONE METYRAPONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09
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.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N012911-001 METOPIRONE 250MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N012911-002 METOPIRONE 250MG CAPSULE / ORAL RLD, RS 1996-08-09 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Metopirone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METYRAPONE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZS9KD92H6V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105450 Internal RxNorm lookup 199772 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76336-455-18 Metopirone 18 in 1 BOTTLE CAPSULE, GELATIN COATED 18 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METYRAPONE ACTIVE INGREDIENT ZS9KD92H6V METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1 METYRAPONE ACTIVE MOIETY ZS9KD92H6V METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1 ETHYL VANILLIN INACTIVE INGREDIENT YC9ST449YJ METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1 PROPYLPARABEN SODIUM INACTIVE INGREDIENT 625NNB0G9N METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [LABORATOIRE HRA PHARMA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76336-455 METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [HRA PHARMA RARE DISEASES] 16 Current NDC, Legacy NDC, 1 package rows 20250201_3a27d0ef-83a7-4e1c-9430-46a3326ee8d8.zip
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 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 76336-455-18 76336045518 18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18) 1962-01-25 0000-00-00 No No Current