NDC codes

FDA NDC Directory
Product NDC (as listed)45963-556Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45963-0556Add 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
45963-556-1145963055611100 CAPSULE in 1 BOTTLE (45963-556-11)Marketed from Apr 3, 2014
45963-556-5045963055650500 CAPSULE in 1 BOTTLE (45963-556-50)Marketed from May 12, 2014

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)
Gabapentin
Generic name (nonproprietary)
gabapentin
Active ingredients
Gabapentin — 300 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075350
Marketing start
Marketing end
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 45963-556_6928cff7-f264-464c-bd54-baf27f13ab18SPL ID 6928cff7-f264-464c-bd54-baf27f13ab18SPL set ID 5969871e-6c71-4c37-9d63-370718ccc80cRxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0345963555113, 0345963556110

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

N445963055611 followed by a unit qualifier and the quantity

Package 45963-0556-11. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 075350

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

FDA NDC Directory listings under ANDA 075350
ProductStrengthForm · routeLabelerProduct NDC
GabapentinGabapentin 300 mg/1CapsuleOralProficient Rx LP63187-988
GabapentinGabapentin 400 mg/1CapsuleOralBryant Ranch Prepack71335-0351
GabapentinGabapentin 100 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-072
GabapentinGabapentin 300 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC43353-075
GabapentinGabapentin 400 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC43353-081
GabapentinGabapentin 100 mg/1CapsuleOralActavis Pharma, Inc.45963-555
GabapentinGabapentin 400 mg/1CapsuleOralProficient Rx LP71205-064
GabapentinGabapentin 400 mg/1CapsuleOralActavis Pharma, Inc.45963-557
GabapentinGabapentin 100 mg/1CapsuleOralAsclemed USA, Inc.76420-014
GabapentinGabapentin 300 mg/1CapsuleOralAsclemed USA, Inc.76420-015
GabapentinGabapentin 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-055
GabapentinGabapentin 300 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0032
GabapentinGabapentin 100 mg/1CapsuleOralTeva Pharmaceuticals, Inc.0480-3494
GabapentinGabapentin 300 mg/1CapsuleOralTeva Pharmaceuticals, Inc.0480-3495
GabapentinGabapentin 400 mg/1CapsuleOralTeva Pharmaceuticals, Inc.0480-3496

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