Midodrine hydrochloride NDC 68382-739

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-739Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0739Add 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
68382-739-01	68382073901	100 TABLET in 1 BOTTLE (68382-739-01)Marketed from Sep 17, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.
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 68382-739_fe679311-db62-4004-800d-2961962340deSPL ID fe679311-db62-4004-800d-2961962340deSPL set ID 3bc97210-fa2f-4979-abdf-d92e5973e6e3RxCUI 993462, 993466, 993470UNII 59JV96YTXVUPC 0368382739018
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

N468382073901 followed by a unit qualifier and the quantity

Package 68382-0739-01. 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, 2024. 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 5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1596
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