Midodrine hydrochloride NDC 70771-1596

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1596Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1596Add 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
70771-1596-1	70771159601	100 TABLET in 1 BOTTLE (70771-1596-1)Marketed from Sep 17, 2020

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): Midodrine hydrochloride
Generic name (nonproprietary): midodrine hydrochloride
Active ingredients: Midodrine hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213055
Marketing start: Sep 17, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)
Identifiers: Product ID 70771-1596_027de750-bb64-4f6c-87ee-9c73862af579SPL ID 027de750-bb64-4f6c-87ee-9c73862af579SPL set ID b4c4417e-d8fd-46c8-b82f-ffbc8f201752RxCUI 993462, 993466, 993470UNII 59JV96YTXV
Pharmacologic class: alpha-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

N470771159601 followed by a unit qualifier and the quantity

Package 70771-1596-01. 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 Nov 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213055

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

FDA NDC Directory listings under ANDA 213055
Product	Strength	Form · route	Labeler	Product NDC
Midodrine hydrochloride	Midodrine hydrochloride 10 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1597
Midodrine hydrochloride	Midodrine hydrochloride 2.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1595
Midodrine hydrochloride	Midodrine hydrochloride 10 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-739
Midodrine hydrochloride	Midodrine hydrochloride 2.5 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-737
Midodrine hydrochloride	Midodrine hydrochloride 5 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-738