NDC codes

FDA NDC Directory
Product NDC (as listed)68071-5264Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-5264Add 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
68071-5264-3680715264036807152640330 TABLET, FILM COATED in 1 BOTTLE (68071-5264-3)Marketed from Jun 1, 2020

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)
Letrozole
Generic name (nonproprietary)
letrozole
Active ingredients
Letrozole — 2.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090934
Marketing start
Listing expires
Other FDA classes
Aromatase Inhibitors (Mechanism)
Identifiers
Product ID 68071-5264_2a849ae9-3398-4642-e063-6394a90a1ca4SPL ID 2a849ae9-3398-4642-e063-6394a90a1ca4SPL set ID a707ec4b-8d26-55c2-e053-2a95a90a2e07RxCUI 200064UNII 7LKK855W8IUPC 0368071526431
Pharmacologic class
Aromatase Inhibitor

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

N468071526403 followed by a unit qualifier and the quantity

Package 68071-5264-03. 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)

Letrozole tablet is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer ( 1.1 ) Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy ( 1.2 ) First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer ( 1.3 ) 1.1 Adjuvant Treatment of Early Breast Cancer Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. 1.2 Extended Adjuvant Treatment of Early Breast Cancer Letrozole tablets are indicate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-5264

What is NDC 68071-5264?
68071-5264 is the product NDC for Letrozole, Letrozole 2.5 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Letrozole.
What is the active ingredient?
Letrozole.
Who is the labeler?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Letrozole?
22 other product NDCs are listed under this name. See all Letrozole 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 Letrozole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralCarnegie Pharmaceuticals LLC80005-13980005-0139-0880005-0139-10
Letrozoleletrozole tabletsLetrozole 2.5 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-72624979-0726-07
Letrozoleletrozole tabletsLetrozole 2.5 mg/1Tablet, Film coatedOralAvet Pharmaceuticals Inc.23155-87523155-0875-0323155-0875-0923155-0875-10
Letrozoleletrozole tabletsLetrozole 2.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-239671335-2396-0171335-2396-0271335-2396-03+1 more
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralATLANTIC BIOLOGICALS CORP.17856-003217856-0032-01
LetrozoleLetrozole 2.5 mg/1TabletOralAvPAK50268-47650268-0476-15
Letrozoleletrozole tabletsLetrozole 2.5 mg/1Tablet, Film coatedOralYiling Pharmaceutical, Inc.69117-000469117-0004-01
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-49162135-0491-3062135-0491-90
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-18059651-0180-3059651-0180-90
Letrozoleletrozole tabletsLetrozole 2.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-98651407-0986-90

All 23 Letrozole NDCs

Other NDCs under ANDA 090934

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

FDA NDC Directory listings under ANDA 090934
ProductStrengthForm · routeLabelerProduct NDC
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-034
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralATLANTIC BIOLOGICALS CORP.17856-0032
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3474
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-7819
LetrozoleLetrozole 2.5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2167

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