Metopirone

Product NDC: 68118-455
Requested package NDC: 68118-455-18
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4046b167-7a46-8f4a-e063-6394a90a147f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
05cc66c6-dbef-0902-b782-c1684bd46672	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68118-455-18	Metopirone	18 in 1 BOTTLE	CAPSULE, GELATIN COATED	18		3

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metopirone	METYRAPONE	ESTEVE PHARMACEUTICALS, S.A.	4046b167-7a46-8f4a-e063-6394a90a147f	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012911 application number: NDA012911 ndc (package): 68118-455-18 ndc (product): 68118-455 ndc11 (package): 68118045518
Metopirone	METYRAPONE	HRA Pharma Rare Diseases	3a27d0ef-83a7-4e1c-9430-46a3326ee8d8	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012911 application number: NDA012911

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZS9KD92H6V	METYRAPONE	54-36-4	METYRAPONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
105450	Metopirone 250 MG Oral Capsule	PSN	4046b167-7a46-8f4a-e063-6394a90a147f	3
199772	metyraPONE 250 MG Oral Capsule	PSN	4046b167-7a46-8f4a-e063-6394a90a147f	3
105450	metyrapone 250 MG Oral Capsule [Metopirone]	SBD	4046b167-7a46-8f4a-e063-6394a90a147f	3
199772	metyrapone 250 MG Oral Capsule	SCD	4046b167-7a46-8f4a-e063-6394a90a147f	3
105450	Metopirone 250 MG Oral Capsule	SY	4046b167-7a46-8f4a-e063-6394a90a147f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68118-455-18	68118045518	18 CAPSULE, GELATIN COATED in 1 BOTTLE (68118-455-18)	1962-01-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metopirone	ESTEVE PHARMACEUTICALS, S.A. \| Minakem Beuvry Production \| Minakem Dunkerque Production \| DELPHARM LILLE SAS \| Catalent Germany Eberbach GmbH \| Piramal Pharma Limited	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	3