What is NDC 70710-1160?

70710-1160 is the product NDC for Mirabegron, Mirabegron 50 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 70710. 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 70710-1160 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70710-1160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70710-1160Add 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
70710-1160-1	70710116001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-1)Marketed from Jan 23, 2024
70710-1160-3	70710116003	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-3)Marketed from Jan 23, 2024
70710-1160-9	70710116009	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-9)Marketed from Jan 23, 2024

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, Extended release
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 70710
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209488
Marketing start: Jan 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta3-Agonists (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 70710-1160_df34c0c9-8528-4fd6-a408-e1d44da0f156SPL ID df34c0c9-8528-4fd6-a408-e1d44da0f156SPL set ID 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2RxCUI 1300791, 1300801UNII MVR3JL3B2V
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

N470710116001 followed by a unit qualifier and the quantity

Package 70710-1160-01. 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 Oct 9, 2024.

Indications (excerpt from the label)

Mirabegron extended-release tablets are 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 extended-release tablets are 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 extended-release tablets are indicated for the treatment of ND…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70710-1160

What is NDC 70710-1160?: 70710-1160 is the product NDC for Mirabegron, Mirabegron 50 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 3 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?: Zydus Pharmaceuticals (USA) Inc., NDC labeler code 70710. 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 50 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals NY LLC	69238-2861	69238-2861-0169238-2861-02
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	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 50 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-152	68180-0152-0668180-0152-09

All 17 Mirabegron NDCs

Other NDCs under ANDA 209488

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

FDA NDC Directory listings under ANDA 209488
Product	Strength	Form · route	Labeler	Product NDC
Mirabegron	Mirabegron 25 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	70710-1159
Mirabegron	Mirabegron 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4304
Mirabegron	Mirabegron 25 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1752
Mirabegron	Mirabegron 50 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1753
Mirabegron	Mirabegron 25 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4631