FDA.reportPublic FDA data

MIRABEGRON

Product NDC
71335-2809
11-digit product format
713352809
Labeler code
71335
Product ID
71335-2809_f6e3a4fc-e24f-4cf0-addf-d4df23f18768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mirabegron
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209485
Marketing category
ANDA
Marketing start
2024-04-19
Substance
MIRABEGRON
Active strength
25 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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209485-001MIRABEGRONMIRABEGRON25MGTABLET, EXTENDED RELEASE / ORALAB2022-09-28
A209485-002MIRABEGRONMIRABEGRON50MGTABLET, EXTENDED RELEASE / ORALAB2022-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209485-001AB
A209485-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209485-001MIRABEGRON25MGTABLET, EXTENDED RELEASE / ORALAB2022-09-28a50c72e98297…
2026-08-01 22:54:322026-06A209485-002MIRABEGRON50MGTABLET, EXTENDED RELEASE / ORALAB2022-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209485-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209485-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIRABEGRONMIRABEGRONREMEDYREPACK INC.d0054db9-e38a-4786-be2c-996fa5b8f47d2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209485
application number: ANDA209485
MIRABEGRONMIRABEGRONLupin Pharmaceuticals, Inc.d22d3d12-8466-46db-bc19-d13e87c6115c2025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209485
application number: ANDA209485
MIRABEGRONMIRABEGRONBryant Ranch Prepack00826723-d25e-498a-b8d4-d17e5c14dda52025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209485
application number: ANDA209485
MIRABEGRONMIRABEGRONBryant Ranch Prepack1a7337a4-2901-4e65-b666-7623fadb78f22025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209485
application number: ANDA209485
MIRABEGRONMIRABEGRONBryant Ranch Prepack2965e083-b678-43b9-8e13-2efddc0daad02025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209485
application number: ANDA209485
ndc (product): 71335-2809
MIRABEGRONMIRABEGRONBryant Ranch Prepack3bd73250-2b31-4b22-983b-15119846e6972025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209485
application number: ANDA209485

Additional Listing Data#

Finished product
Yes
Brand name base
MIRABEGRON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRABEGRON25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MVR3JL3B2VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1300791Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2965e083-b678-43b9-8e13-2efddc0daad0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c73f394f-7cf1-bcd8-df99-a95ef4373ff6Product name420250116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2809-1MIRABEGRON90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE90100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2809-1EA - Each71335-2809291e8194-4ad6-439a-a67c-1a610a93072c12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300791mirabegron 25 MG 24HR Extended Release Oral TabletPSN2965e083-b678-43b9-8e13-2efddc0daad0100
130079124 HR mirabegron 25 MG Extended Release Oral TabletSCD2965e083-b678-43b9-8e13-2efddc0daad0100
1300791mirabegron 25 MG 24 HR Release TabletSY2965e083-b678-43b9-8e13-2efddc0daad0100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2809-17133528090190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2809-1) 2025-09-26NoNoCurrent