Home NDC 0310-0075 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 · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220359-001 ETCAMAH CAMIZESTRANT 75MG TABLET / ORAL RLD, RS 2026-09-04
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220359-001 10131663 2037-10-13 Drug substance, Drug product 2026-09-30 N220359-001 10590130 2037-10-13 Drug substance, Drug product 2026-09-30 N220359-001 10961241 2037-10-13 U-4607 2026-09-30 N220359-001 12077530 2037-10-13 U-4607 2026-09-30 N220359-001 12364689 2041-09-18 U-4606 2026-09-30 N220359-001 12453729 2041-10-22 Drug product 2026-09-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220359-001 NCE 2031-09-04
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.
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 2026-10-15 13:18:30 2026-09 N220359-001 ETCAMAH 75MG TABLET / ORAL RLD, RS 2026-09-04 c2088c7a36db…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N220359-001 10131663 2037-10-13 Drug substance, Drug product 2026-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220359-001 10590130 2037-10-13 Drug substance, Drug product 2026-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220359-001 10961241 2037-10-13 U-4607 2026-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220359-001 12077530 2037-10-13 U-4607 2026-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220359-001 12364689 2041-09-18 U-4606 2026-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220359-001 12453729 2041-10-22 Drug product 2026-09-30 c2088c7a36db…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 N220359-001 NCE 2031-09-04 c2088c7a36db…
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 Ingredient Strength CAMIZESTRANT 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JUP57A8EPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2752687 Internal RxNorm lookup 2752693 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ETCAMAH CAMIZESTRANT AstraZeneca Pharmaceuticals LP c54223d3-f3c7-4186-afa0-429d84805826 2026-09-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 220359 application number: NDA220359 ndc (product): 0310-0075
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0310-0075-01 00310007501 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01) 2026-09-04 No No Current 0310-0075-95 00310007595 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-95) 2026-09-04 Yes No Current