NDC codes

FDA NDC Directory
Product NDC (as listed)70518-0053Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-0053Add 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
70518-0053-07051800530030 CAPSULE in 1 BLISTER PACK (70518-0053-0)Marketed from Dec 12, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 400 mg/1
Dosage form
Capsule
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090858
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 70518-0053_5c01e5b6-45b4-fd38-e063-6294a90a754bSPL ID 5c01e5b6-45b4-fd38-e063-6294a90a754b

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

N470518005300 followed by a unit qualifier and the quantity

Package 70518-0053-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70518-0053

What is NDC 70518-0053?
70518-0053 is the product NDC for Gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gabapentin.
What is the active ingredient?
Gabapentin.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gabapentin?
558 other product NDCs are listed under this name. See all Gabapentin 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 Gabapentin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
gabapentinGabapentin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-476370518-4763-00
GabapentinGabapentin 100 mg/1CapsuleOralCardinal Health 107, LLC55154-058155154-0581-00
GabapentinGabapentin 100 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-059580425-0595-0180425-0595-0280425-0595-03+1 more
GabapentinGabapentin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-474670518-4746-0070518-4746-0170518-4746-02
GabapentinGabapentin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-474270518-4742-00
GabapentinGabapentin 400 mg/1CapsuleOralREMEDYREPACK INC.70518-474070518-4740-00
GabapentinGabapentin 300 mg/1CapsuleOralCardinal Health 107, LLC55154-058055154-0580-00
GabapentinGabapentin 600 mg/1Tablet, CoatedOralCoupler LLC67046-123367046-1233-03
GabapentinGabapentin 200 mg/1CapsuleOralTrifluent Pharma, LLC73352-23173352-0231-01
GabapentinGabapentin 600 mg/1TabletOralCoupler LLC67046-108667046-1086-03

All 559 Gabapentin NDCs

Other NDCs under ANDA 090858

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

FDA NDC Directory listings under ANDA 090858
ProductStrengthForm · routeLabelerProduct NDC
GabapentinGabapentin 100 mg/1CapsuleOralMajor Pharmaceuticals0904-6665
GabapentinGabapentin 300 mg/1CapsuleOralMajor Pharmaceuticals0904-6666
GabapentinGabapentin 400 mg/1CapsuleOralMajor Pharmaceuticals0904-6667
GabapentinGabapentin 100 mg/1CapsuleOralMajor Pharmaceuticals0904-7613
GabapentinGabapentin 300 mg/1CapsuleOralMajor Pharmaceuticals0904-7614
GabapentinGabapentin 400 mg/1CapsuleOralMajor Pharmaceuticals0904-7615
GabapentinGabapentin 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-673
GabapentinGabapentin 300 mg/1CapsuleOralA-S Medication Solutions50090-0896
GabapentinGabapentin 100 mg/1CapsuleOralA-S Medication Solutions50090-3200
GabapentinGabapentin 300 mg/1CapsuleOralA-S Medication Solutions50090-4893
GabapentinGabapentin 100 mg/1CapsuleOralA-S Medication Solutions50090-7169
GabapentinGabapentin 400 mg/1CapsuleOralCardinal Health 107, LLC55154-0579
GabapentinGabapentin 300 mg/1CapsuleOralCardinal Health 107, LLC55154-0580
GabapentinGabapentin 100 mg/1CapsuleOralCardinal Health 107, LLC55154-0581
GabapentinGabapentin 100 mg/1CapsuleOralCardinal Health 107, LLC55154-3363
GabapentinGabapentin 300 mg/1CapsuleOralCardinal Health 107, LLC55154-7992
GabapentinGabapentin 400 mg/1CapsuleOralCardinal Health 107, LLC55154-7993
GabapentinGabapentin 100 mg/1CapsuleOralCardinal Health 107, LLC55154-8194
GabapentinGabapentin 300 mg/1CapsuleOralCardinal Health 107, LLC55154-8195
GabapentinGabapentin 400 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-3224

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