NDC codes

FDA NDC Directory
Product NDC (as listed)13668-605Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0605Add 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
13668-605-0513668060505136680605051 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMPMarketed from Feb 10, 2022
13668-605-0813668060508136680605081 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 90 g in 1 BOTTLE, PUMPMarketed from Feb 10, 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)
dapsone
Generic name (nonproprietary)
dapsone
Active ingredients
Dapsone — 75 mg/g
Dosage form
Gel
Route
Topical
Labeler
Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214722
Marketing start
Listing expires
Other FDA classes
Sulfones (Chemical structure)
Identifiers
Product ID 13668-605_2c733874-9036-42d0-8820-d5a4a35b5adcSPL ID 2c733874-9036-42d0-8820-d5a4a35b5adcSPL set ID f8cffc24-8310-4f21-ae77-7f6ad6095551RxCUI 1741905UNII 8W5C518302
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N413668060505 followed by a unit qualifier and the quantity

Package 13668-0605-05. 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)

Dapsone gel, 7.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5% is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13668-605

What is NDC 13668-605?
13668-605 is the product NDC for dapsone, Dapsone 75 mg/g gel, listed with the FDA by Torrent Pharmaceuticals Limited. 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?
Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 214722

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

FDA NDC Directory listings under ANDA 214722
ProductStrengthForm · routeLabelerProduct NDC
DapsoneDapsone 75 mg/gGelTopicalMayne Pharma Commercial LLC68308-342

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in