NDC codes

FDA NDC Directory
Product NDC (as listed)51672-5278Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-5278Add 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
51672-5278-351672527803516725278031 TUBE in 1 CARTON (51672-5278-3) / 60 g in 1 TUBEMarketed from Mar 24, 2010
51672-5278-451672527804516725278041 TUBE in 1 CARTON (51672-5278-4) / 120 g in 1 TUBEMarketed from Mar 24, 2010
51672-5278-5516725278055167252780510 TUBE in 1 CARTON (51672-5278-5) / 5 g in 1 TUBEMarketed from Mar 24, 2010

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)
Calcitrene
Generic name (nonproprietary)
calcipotriene
Active ingredients
Calcipotriene — .05 mg/g
Dosage form
Ointment
Route
Topical
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090633
Marketing start
Listing expires
Other FDA classes
Vitamin D (Chemical structure)
Identifiers
Product ID 51672-5278_5698b4f1-b04f-1b1f-e063-6394a90ae022SPL ID 5698b4f1-b04f-1b1f-e063-6394a90ae022SPL set ID 94d4f46a-f254-4fe2-b4bd-7a533d6324feRxCUI 198373, 1013636UNII 143NQ3779B
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

N451672527803 followed by a unit qualifier and the quantity

Package 51672-5278-03. 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 Calcitrene ® (calcipotriene) ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. 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 51672-5278

What is NDC 51672-5278?
51672-5278 is the product NDC for Calcitrene (calcipotriene), Calcipotriene .05 mg/g ointment, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Calcitrene (Calcipotriene).
What is the active ingredient?
Calcipotriene.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Calcitrene?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 090633

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

FDA NDC Directory listings under ANDA 090633
ProductStrengthForm · routeLabelerProduct NDC
CalcipotrieneCalcipotriene .05 mg/gOintmentTopicalSun Pharmaceutical Industries, Inc.51672-4154
CalcipotrieneCalcipotriene 50 ug/gOintmentTopicalGlenmark Pharmaceuticals Inc., USA68462-310

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