NDC codes

FDA NDC Directory
Product NDC (as listed)16571-869Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16571-0869Add 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
16571-869-011657108690116571086901100 CAPSULE in 1 BOTTLE (16571-869-01)Marketed from Aug 1, 2022
16571-869-03165710869031657108690330 CAPSULE in 1 BOTTLE (16571-869-03)Marketed from Aug 1, 2022
16571-869-1016571086910165710869101000 CAPSULE in 1 BOTTLE (16571-869-10)Marketed from Aug 1, 2022
16571-869-501657108695016571086950500 CAPSULE in 1 BOTTLE (16571-869-50)Marketed from Aug 1, 2022

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 — 400 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207099
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 16571-869_2e493243-47c0-460e-bea9-4ed0261adf90SPL ID 2e493243-47c0-460e-bea9-4ed0261adf90SPL set ID 969cccfc-e56a-49da-9d36-47c0c3fad7f8RxCUI 310430, 310431, 310432UNII 6CW7F3G59X

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

N416571086901 followed by a unit qualifier and the quantity

Package 16571-0869-01. 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)

Gabapentin Capsules are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin capsules are indicated for: Postherpetic neuralgia in adults ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-869

What is NDC 16571-869?
16571-869 is the product NDC for gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 4 package NDCs, 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?
Rising Pharma Holdings, Inc., NDC labeler code 16571. 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?
561 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 800 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-94360760-0943-3060760-0943-90
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+1 more
GabapentinGabapentin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-474270518-4742-0070518-4742-02
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

All 562 gabapentin NDCs

Other NDCs under ANDA 207099

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

FDA NDC Directory listings under ANDA 207099
ProductStrengthForm · routeLabelerProduct NDC
gabapentinGabapentin 100 mg/1CapsuleOralRising Pharma Holdings, Inc.16571-867
gabapentinGabapentin 300 mg/1CapsuleOralRising Pharma Holdings, Inc.16571-868
GabapentinGabapentin 100 mg/1CapsuleOralEpic Pharma, LLC42806-509
GabapentinGabapentin 300 mg/1CapsuleOralEpic Pharma, LLC42806-510
GabapentinGabapentin 400 mg/1CapsuleOralEpic Pharma, LLC42806-511
GabapentinGabapentin 300 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-674
gabapentinGabapentin 400 mg/1CapsuleOralCoupler LLC67046-1591
gabapentinGabapentin 300 mg/1CapsuleOralCoupler LLC67046-1644
gabapentinGabapentin 300 mg/1CapsuleOralNuCare Pharmaceuticals, Inc.68071-5317
gabapentinGabapentin 400 mg/1CapsuleOralREMEDYREPACK INC.70518-4482
gabapentinGabapentin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-4706
gabapentinGabapentin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-4763
GabapentinGabapentin 400 mg/1CapsuleOralDirect_Rx72189-524
GabapentinGabapentin 300 mg/1CapsuleOralDirect_Rx72189-610
GabapentinGabapentin 300 mg/1CapsuleOralProficient Rx LP82804-206
gabapentinGabapentin 400 mg/1CapsuleOralProficient Rx LP82804-294
gabapentinGabapentin 300 mg/1CapsuleOralNorthwind Health Company, LLC82868-073

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