Home NDC 67877-890 Mirabegron
Product NDC 67877-890
11-digit product format 678770890
Labeler code 67877
Product ID 67877-890_bea3fc38-dab4-4a11-b7a1-911b302f6504
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirabegron
Dosage form FOR SUSPENSION, EXTENDED RELEASE
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA219323
Marketing category ANDA
Marketing start 2026-06-15
Substance MIRABEGRON
Active strength 8 mg/mL
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 43 .
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 A219323-001 MIRABEGRON MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219323-001 AB
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 2026-09-14 22:38:34 2026-08 A219323-001 MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219323-001 MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219323-001 MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219323-001 MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 Mirabegron
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIRABEGRON 8 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2541233 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 67877-890-88 Mirabegron 1 in 1 POUCH FOR SUSPENSION, EXTENDED RELEASE 1 6 67877-890-88 Mirabegron 1 in 1 CARTON FOR SUSPENSION, EXTENDED RELEASE 1 6
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 Units Marketing start Sample Exclude flag Status 67877-890-88 67877089088 1 POUCH in 1 CARTON (67877-890-88) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE 1 pouch 2026-06-15 No No Current