Home NDC 69238-2861 Mirabegron
Product NDC 69238-2861
11-digit product format 692382861
Labeler code 69238
Product ID 69238-2861_0bfa52f0-d4b2-4fb1-b3ee-da4cba2b18fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirabegron
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA218543
Marketing category ANDA
Marketing start 2026-04-19
Substance MIRABEGRON
Active strength 50 mg/1
Pharmacologic classes Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]
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 42 .
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 A218543-001 MIRABEGRON MIRABEGRON 25MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 A218543-002 MIRABEGRON MIRABEGRON 50MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-08-18 06:07:40 2026-07 A218543-001 MIRABEGRON 25MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218543-002 MIRABEGRON 50MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218543-001 MIRABEGRON 25MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218543-002 MIRABEGRON 50MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218543-001 MIRABEGRON 25MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218543-002 MIRABEGRON 50MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218543-001 MIRABEGRON 25MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218543-002 MIRABEGRON 50MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-04 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Mirabegron
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIRABEGRON 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MVR3JL3B2V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1300791 Internal RxNorm lookup 1300801 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 69238-2861-1 Mirabegron 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 4 69238-2861-2 Mirabegron 90 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 90 4
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69238-2861-1 69238286101 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2861-1) 2026-04-19 No No Current 69238-2861-2 69238286102 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2861-2) 2026-04-19 No No Current