FDA.reportPublic FDA data

ETCAMAH

Product NDC
0310-0075
11-digit product format
003100075
Labeler code
0310
Product ID
0310-0075_c54223d3-f3c7-4186-afa0-429d84805826
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
camizestrant
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA220359
Marketing category
NDA
Marketing start
2026-09-04
Substance
CAMIZESTRANT
Active strength
75 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

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
ETCAMAH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMIZESTRANT75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JUP57A8EPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2752687Internal RxNorm lookup
2752693Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c54223d3-f3c7-4186-afa0-429d84805826Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ETCAMAHCAMIZESTRANTAstraZeneca Pharmaceuticals LPc54223d3-f3c7-4186-afa0-429d848058262026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 220359
application number: NDA220359
ndc (product): 0310-0075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0310-0075-010031000750128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01) 2026-09-04NoNoCurrent
0310-0075-95003100075957 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-95) 2026-09-04YesNoCurrent