NDC codes

FDA NDC Directory
Product NDC (as listed)0245-0211Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00245-0211Add 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 NDC11-digit (billing)PackageCopy
0245-0211-010024502110100245021101100 BLISTER PACK in 1 CARTON (0245-0211-01) / 1 TABLET in 1 BLISTER PACK (0245-0211-89)Marketed from Nov 3, 2004
0245-0211-110024502111100245021111100 TABLET in 1 BOTTLE (0245-0211-11)Marketed from Nov 3, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Upsher-Smith laboratories, LLCNDC labeler code 0245
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076725
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 0245-0211_18b0b9f5-6026-479e-af12-92b0e71a9d6bSPL ID 18b0b9f5-6026-479e-af12-92b0e71a9d6bSPL set ID 4c3517f3-1c68-4ade-b5f1-c488a3a335c1RxCUI 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

N400245021101 followed by a unit qualifier and the quantity

Package 00245-0211-01. 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 . 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'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 of midodrine hydrochlori…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0245-0211

What is NDC 0245-0211?
0245-0211 is the product NDC for Midodrine Hydrochloride, Midodrine hydrochloride 2.5 mg/1 tablet, listed with the FDA by Upsher-Smith laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Midodrine Hydrochloride.
What is the active ingredient?
Midodrine hydrochloride.
Who is the labeler?
Upsher-Smith laboratories, LLC, NDC labeler code 0245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Midodrine Hydrochloride?
108 other product NDCs are listed under this name. See all Midodrine Hydrochloride 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 Midodrine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Midodrine HydrochlorideMidodrine hydrochloride 2.5 mg/1TabletOralMajor Pharmaceuticals0904-764000904-7640-0600904-7640-61
Midodrine HydrochlorideMidodrine hydrochloride 5 mg/1TabletOralMajor Pharmaceuticals0904-764100904-7641-0600904-7641-61
Midodrine HydrochlorideMidodrine hydrochloride 10 mg/1TabletOralMajor Pharmaceuticals0904-764200904-7642-07
Midodrine HydrochlorideMidodrine hydrochloride 2.5 mg/1TabletOralNorthStar RxLLC72603-90672603-0906-0572603-0906-10
Midodrine HydrochlorideMidodrine hydrochloride 5 mg/1TabletOralNorthStar RxLLC72603-90772603-0907-0572603-0907-10
Midodrine HydrochlorideMidodrine hydrochloride 10 mg/1TabletOralNorthStar RxLLC72603-90872603-0908-0372603-0908-05
Midodrine HydrochlorideMidodrine hydrochloride 2.5 mg/1TabletOralAvet Pharmaceuticals Inc.23155-96923155-0969-01
Midodrine HydrochlorideMidodrine hydrochloride 5 mg/1TabletOralAvet Pharmaceuticals Inc.23155-97023155-0970-01
Midodrine HydrochlorideMidodrine hydrochloride 10 mg/1TabletOralAvet Pharmaceuticals Inc.23155-97123155-0971-01
Midodrine HydrochlorideMidodrine hydrochloride 5 mg/1TabletOralSafecor Health LLC48433-07548433-0075-20

All 109 Midodrine Hydrochloride NDCs

Other NDCs under ANDA 076725

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

FDA NDC Directory listings under ANDA 076725
ProductStrengthForm · routeLabelerProduct NDC
Midodrine HydrochlorideMidodrine hydrochloride 5 mg/1TabletOralUpsher-Smith laboratories, LLC0245-0212
Midodrine HydrochlorideMidodrine hydrochloride 10 mg/1TabletOralUpsher-Smith laboratories, LLC0245-0213
Midodrine HydrochlorideMidodrine hydrochloride 2.5 mg/1TabletOralAvet Pharmaceuticals Inc.23155-969
Midodrine HydrochlorideMidodrine hydrochloride 5 mg/1TabletOralAvet Pharmaceuticals Inc.23155-970
Midodrine HydrochlorideMidodrine hydrochloride 10 mg/1TabletOralAvet Pharmaceuticals Inc.23155-971
Midodrine HydrochlorideMidodrine hydrochloride 5 mg/1TabletOralCardinal Health 107, LLC55154-5623

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