NDC codes

FDA NDC Directory
Product NDC (as listed)70954-135Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70954-0135Add 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
70954-135-10709540135107095401351030 TABLET in 1 BOTTLE (70954-135-10)Marketed from Jan 15, 2018
70954-135-207095401352070954013520100 TABLET in 1 BOTTLE (70954-135-20)Marketed from Jan 15, 2018

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)
Dapsone
Generic name (nonproprietary)
dapsone
Active ingredients
Dapsone — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206505
Marketing start
Listing expires
Other FDA classes
Sulfones (Chemical structure)
Identifiers
Product ID 70954-135_846ff8b6-d395-4e67-98ea-9dbfd688b97eSPL ID 846ff8b6-d395-4e67-98ea-9dbfd688b97eSPL set ID 57a47368-d1f6-4d61-a2ee-c5f1fe7ff690RxCUI 197557, 197558UNII 8W5C518302UPC 0370954135104, 0370954136200, 0370954135203, 0370954136101
Pharmacologic class
Sulfone

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

N470954013510 followed by a unit qualifier and the quantity

Package 70954-0135-10. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70954-135

What is NDC 70954-135?
70954-135 is the product NDC for Dapsone, Dapsone 25 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dapsone.
What is the active ingredient?
Dapsone.
Who is the labeler?
ANI Pharmaceuticals, Inc., NDC labeler code 70954. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dapsone?
45 other product NDCs are listed under this name. See all Dapsone 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 Dapsone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DapsoneDapsone 25 mg/1TabletOralMacleods Pharmaceuticals Limited33342-53433342-0534-0733342-0534-11
DapsoneDapsone 100 mg/1TabletOralMacleods Pharmaceuticals Limited33342-53533342-0535-0733342-0535-11
DapsoneDapsone 50 mg/gGelTopicalAlembic Pharmaceuticals Limited46708-55146708-0551-3046708-0551-6046708-0551-90
DapsoneDapsone 50 mg/gGelTopicalAlembic Pharmaceuticals Inc.62332-55162332-0551-3062332-0551-6062332-0551-90
DapsoneDapsone 25 mg/1TabletOralZydus Lifesciences Limited70771-197970771-1979-0170771-1979-03
DapsoneDapsone 100 mg/1TabletOralZydus Lifesciences Limited70771-198070771-1980-0170771-1980-03
DapsoneDapsone 25 mg/1TabletOralViona Pharmaceuticals Inc72578-17772578-0177-0172578-0177-06
DapsoneDapsone 100 mg/1TabletOralViona Pharmaceuticals Inc72578-17872578-0178-0172578-0178-06
DapsoneDapsone 25 mg/1TabletOralAvKARE73190-03773190-0037-01
DapsoneDapsone 25 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-40969367-0409-0169367-0409-30

All 46 Dapsone NDCs

Other NDCs under ANDA 206505

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

FDA NDC Directory listings under ANDA 206505
ProductStrengthForm · routeLabelerProduct NDC
DapsoneDapsone 100 mg/1TabletOralANI Pharmaceuticals, Inc.70954-136

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