NDC codes

FDA NDC Directory
Product NDC (as listed)50228-355Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0355Add 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
50228-355-0550228035505500 CAPSULE in 1 BOTTLE (50228-355-05)Marketed from Jul 19, 2019
50228-355-305022803553030 CAPSULE in 1 BOTTLE (50228-355-30)Marketed from Jul 19, 2019
50228-355-905022803559090 CAPSULE in 1 BOTTLE (50228-355-90)Marketed from Jul 19, 2019

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)
Pregabalin
Generic name (nonproprietary)
pregabalin
Active ingredients
Pregabalin — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
ScieGen Pharmaceuticals, IncNDC labeler code 50228
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 50228-355_955253a7-d80a-44ef-83c4-74b33ee6a622SPL ID 955253a7-d80a-44ef-83c4-74b33ee6a622SPL set ID 33ef1a3b-554f-4a51-afdb-92a019e8c16cRxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0350228356053, 0350228354301, 0350228355056, 0350228357050, 0350228352901, 0350228357906, 0350228356909, 0350228350907, 0350228354103, 0350228350105, 0350228353908, 0350228351904, 0350228354905, 0350228355902, 0350228352307, 0350228352109, 0350228353106, 0350228351102

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

N450228035505 followed by a unit qualifier and the quantity

Package 50228-0355-05. 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 .

Indications (excerpt from the label)

Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1 ) Fibromyalgia ( 1 ) Neuropathic pain associated with spinal cord injury ( 1 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50228-355

What is NDC 50228-355?
50228-355 is the product NDC for Pregabalin, Pregabalin 200 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pregabalin.
What is the active ingredient?
Pregabalin.
Who is the labeler?
ScieGen Pharmaceuticals, Inc, NDC labeler code 50228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pregabalin?
509 other product NDCs are listed under this name. See all Pregabalin 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 Pregabalin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PregabalinPregabalin 200 mg/1CapsuleOralREMEDYREPACK INC.70518-474970518-4749-00
PregabalinPregabalin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-474370518-4743-00
PregabalinPregabalin 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 300 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44629300-0446-19
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-471570518-4715-00
PregabalinPregabalin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-471670518-4716-00
PregabalinPregabalin 225 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44529300-0445-19
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 208677

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

FDA NDC Directory listings under ANDA 208677
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 200 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-329
PregabalinPregabalin 225 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-580
PregabalinPregabalin 100 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-591
PregabalinPregabalin 300 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-581
PregabalinPregabalin 225 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-330
PregabalinPregabalin 300 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-331
PregabalinPregabalin 25 mg/1CapsuleOralQuality Care Products, LLC55700-827
PregabalinPregabalin 75 mg/1CapsuleOralST. MARY'S MEDICAL PARK PHARMACY60760-485
PregabalinPregabalin 225 mg/1CapsuleOralDirect Rx72189-328
PregabalinPregabalin 150 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-507
PregabalinPregabalin 150 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-719
PregabalinPregabalin 200 mg/1CapsuleOralQuality Care Products, LLC55700-964
PregabalinPregabalin 50 mg/1CapsuleOralBryant Ranch Prepack63629-8195
PregabalinPregabalin 75 mg/1CapsuleOralBryant Ranch Prepack63629-8196
PregabalinPregabalin 50 mg/1CapsuleOralProficient Rx LP71205-556
PregabalinPregabalin 25 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-645
PregabalinPregabalin 100 mg/1CapsuleOralBryant Ranch Prepack63629-8197
PregabalinPregabalin 50 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-646
PregabalinPregabalin 150 mg/1CapsuleOralBryant Ranch Prepack63629-8198
PregabalinPregabalin 75 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-647

Showing 20 of 40.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in