What is NDC 69238-2861?

69238-2861 is the product NDC for Mirabegron, Mirabegron 50 mg/1 tablet, film coated, extended release, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mirabegron?

16 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mirabegron NDC 69238-2861 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-2861Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-2861Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
69238-2861-1	69238286101	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2861-1)Marketed from Apr 19, 2026
69238-2861-2	69238286102	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2861-2)Marketed from Apr 19, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Mirabegron
Generic name (nonproprietary): mirabegron
Active ingredients: Mirabegron — 50 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218543
Marketing start: Apr 19, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta3-Agonists (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 69238-2861_0bfa52f0-d4b2-4fb1-b3ee-da4cba2b18fdSPL ID 0bfa52f0-d4b2-4fb1-b3ee-da4cba2b18fdSPL set ID e597023d-6dcc-4d9e-8ce0-2d28a5d862f3RxCUI 1300791, 1300801UNII MVR3JL3B2VUPC 0369238286021, 0369238286120
Pharmacologic class: beta3-Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469238286101 followed by a unit qualifier and the quantity

Package 69238-2861-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 26, 2026.

Indications (excerpt from the label)

Mirabegron is a beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Monotherapy Mirabegron is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron Mirabegron is indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-2861

What is NDC 69238-2861?: 69238-2861 is the product NDC for Mirabegron, Mirabegron 50 mg/1 tablet, film coated, extended release, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mirabegron.
What is the active ingredient?: Mirabegron.
Who is the labeler?: Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mirabegron?: 16 other product NDCs are listed under this name. See all Mirabegron NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Mirabegron NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mirabegron	Mirabegron 8 mg/mL	For suspension, Extended releaseOral	Ascend Laboratories, LLC	67877-890	67877-0890-88
Mirabegron	Mirabegron 50 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4665	70518-4665-00
Mirabegron	Mirabegron 25 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4631	70518-4631-00
Mirabegron	Mirabegron 25 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals NY LLC	69238-2860	69238-2860-0169238-2860-02
Mirabegron	Mirabegron 25 mg/1	Tablet, Film coated, Extended releaseOral	Qilu Pharmaceutical Co., Ltd.	67184-0571	67184-0571-0167184-0571-02
Mirabegron	Mirabegron 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4304	70518-4304-00
Mirabegron	Mirabegron 50 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-152	68180-0152-0668180-0152-09
Mirabegron	Mirabegron 50 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-2808	71335-2808-01
Mirabegron	Mirabegron 50 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-2810	71335-2810-01
Mirabegron	Mirabegron 25 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-151	68180-0151-0668180-0151-09

All 17 Mirabegron NDCs

Other NDCs under ANDA 218543

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218543
Product	Strength	Form · route	Labeler	Product NDC
Mirabegron	Mirabegron 25 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals NY LLC	69238-2860