Prescription drug · ANDA

Aripiprazole NDC 50228-328

Aripiprazole 20 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)50228-328Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0328Add 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
50228-328-10502280328101000 TABLET in 1 BOTTLE (50228-328-10)Marketed from Sep 29, 2016
50228-328-305022803283030 TABLET in 1 BOTTLE (50228-328-30)Marketed from Sep 29, 2016

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)
Aripiprazole
Generic name (nonproprietary)
aripiprazole
Active ingredients
Aripiprazole — 20 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206383
Marketing start
Listing expires
Identifiers
Product ID 50228-328_8fbc9a67-ee90-4b5d-b9be-a037bef430deSPL ID 8fbc9a67-ee90-4b5d-b9be-a037bef430deSPL set ID 95954ba3-e838-4dd7-aef1-c51ac6aff76bRxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0350228324106, 0350228328302, 0350228324304, 0350228329309, 0350228325301, 0350228327107, 0350228326100, 0350228327305, 0350228329101, 0350228326308, 0350228328104, 0350228325103
Pharmacologic class
Atypical Antipsychotic

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

N450228032810 followed by a unit qualifier and the quantity

Package 50228-0328-10. 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)

Aripiprazole tablets are indicated for the treatment of: • Schizophrenia [see Clinical Studies ( 14.1 )] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: • Schizophrenia ( 14.1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206383

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

FDA NDC Directory listings under ANDA 206383
ProductStrengthForm · routeLabelerProduct NDC
AripiprazoleAripiprazole 15 mg/1TabletOralDr.Reddys Laboratories Inc43598-968
AripiprazoleAripiprazole 2 mg/1TabletOralDr.Reddys Laboratories Inc43598-965
AripiprazoleAripiprazole 5 mg/1TabletOralDr.Reddys Laboratories Inc43598-966
AripiprazoleAripiprazole 10 mg/1TabletOralDr.Reddys Laboratories Inc43598-967
AripiprazoleAripiprazole 20 mg/1TabletOralDr.Reddys Laboratories Inc43598-969
AripiprazoleAripiprazole 30 mg/1TabletOralDr.Reddys Laboratories Inc43598-970
AripiprazoleAripiprazole 10 mg/1TabletOralScieGen Pharmaceuticals Inc50228-326
AripiprazoleAripiprazole 2 mg/1TabletOralScieGen Pharmaceuticals Inc50228-324
AripiprazoleAripiprazole 5 mg/1TabletOralScieGen Pharmaceuticals Inc50228-325
AripiprazoleAripiprazole 15 mg/1TabletOralScieGen Pharmaceuticals Inc50228-327
AripiprazoleAripiprazole 30 mg/1TabletOralScieGen Pharmaceuticals Inc50228-329
AripiprazoleAripiprazole 15 mg/1TabletOralDr.Reddys Laboratories Inc43598-557
AripiprazoleAripiprazole 2 mg/1TabletOralDr.Reddys Laboratories Inc43598-554
AripiprazoleAripiprazole 5 mg/1TabletOralDr.Reddys Laboratories Inc43598-555
AripiprazoleAripiprazole 10 mg/1TabletOralDr.Reddys Laboratories Inc43598-556
AripiprazoleAripiprazole 20 mg/1TabletOralDr.Reddys Laboratories Inc43598-558
AripiprazoleAripiprazole 30 mg/1TabletOralDr.Reddys Laboratories Inc43598-559
AripiprazoleAripiprazole 5 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8375
AripiprazoleAripiprazole 2 mg/1TabletOralScieGen Pharmaceuticals Inc50228-475
AripiprazoleAripiprazole 20 mg/1TabletOralScieGen Pharmaceuticals Inc50228-479

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Aripiprazole NDC 50228-328 | Med-Code