NDC codes

FDA NDC Directory
Product NDC (as listed)0713-0318Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00713-0318Add 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
0713-0318-5300713031853007130318531 BOTTLE in 1 CARTON (0713-0318-53) / 60 mL in 1 BOTTLEMarketed from Mar 24, 2011

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Calcipotriene
Generic name (nonproprietary)
calcipotriene
Active ingredients
Calcipotriene — .05 mg/mL
Dosage form
Solution
Route
Topical
Labeler
Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078468
Marketing start
Listing expires
Other FDA classes
Vitamin D (Chemical structure)
Identifiers
Product ID 0713-0318_ed81406a-8c10-5c33-e053-2a95a90a941fSPL ID ed81406a-8c10-5c33-e053-2a95a90a941fSPL set ID 21378c25-5622-8bf7-1a8c-b05940a846a0RxCUI 308865UNII 143NQ3779BUPC 0307130318532
Pharmacologic class
Vitamin D Analog

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

N400713031853 followed by a unit qualifier and the quantity

Package 00713-0318-53. 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)

INDICATIONS AND USAGE Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0318

What is NDC 0713-0318?
0713-0318 is the product NDC for Calcipotriene, Calcipotriene .05 mg/mL solution, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Calcipotriene.
What is the active ingredient?
Calcipotriene.
Who is the labeler?
Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Calcipotriene?
7 other product NDCs are listed under this name. See all Calcipotriene 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 Calcipotriene NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
calcipotrieneCalcipotriene 50 ug/gAerosol, FoamTopicalMayne Pharma51862-51251862-0512-60
calcipotrieneCalcipotriene 50 ug/gCreamTopicalGlenmark Pharmaceuticals Inc.,USA68462-50168462-0501-6568462-0501-66
calcipotrieneCalcipotriene 50 ug/gCreamTopicalNorthstar Rx LLC16714-76316714-0763-0116714-0763-02
calcipotrieneCalcipotriene 50 ug/gOintmentTopicalPrasco Laboratories66993-87866993-0878-6166993-0878-78
CalcipotrieneCalcipotriene .05 mg/gOintmentTopicalSun Pharmaceutical Industries, Inc.51672-415451672-4154-0351672-4154-0451672-4154-05
CalcipotrieneCalcipotriene 50 ug/gOintmentTopicalGlenmark Pharmaceuticals Inc., USA68462-31068462-0310-6568462-0310-66
CalcipotrieneCalcipotriene 50 ug/gCreamTopicalPrasco Laboratories66993-87766993-0877-6166993-0877-78

Other NDCs under ANDA 078468

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

FDA NDC Directory listings under ANDA 078468
ProductStrengthForm · routeLabelerProduct NDC
PellixcalcipotrieneCalcipotriene .05 mg/mLSolutionTopicalPerfero Pharma, Inc.87143-300

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