What is NDC 50228-350?

50228-350 is the product NDC for Pregabalin, Pregabalin 25 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pregabalin NDC 50228-350 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-350Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0350Add 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
50228-350-10	50228035010	1000 CAPSULE in 1 BOTTLE (50228-350-10)Marketed from Jul 19, 2019
50228-350-30	50228035030	30 CAPSULE in 1 BOTTLE (50228-350-30)Marketed from Jul 19, 2019
50228-350-90	50228035090	90 CAPSULE in 1 BOTTLE (50228-350-90)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 — 25 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: Jul 19, 2019
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 50228-350_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

N450228035010 followed by a unit qualifier and the quantity

Package 50228-0350-10. 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 Oct 15, 2025.

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 50228-350

What is NDC 50228-350?: 50228-350 is the product NDC for Pregabalin, Pregabalin 25 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4749	70518-4749-00
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4743	70518-4743-00
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-442	29300-0442-19
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-439	29300-0439-19
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-440	29300-0440-19
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-441	29300-0441-19
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-446	29300-0446-19
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-443	29300-0443-19
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-444	29300-0444-19
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-445	29300-0445-19

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
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-353
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-351
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-352
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-677
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7520
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7521
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Proficient Rx LP	82804-274
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7522
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-694
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7523
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7524
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Proficient Rx LP	71205-696
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-097
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-618
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7527
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-095
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-096
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Proficient Rx LP	82804-049
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-098
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-619

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