NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1526Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1526Add 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
71335-1526-17133515260130 TABLET in 1 BOTTLE (71335-1526-1)Marketed from Feb 1, 2021
71335-1526-27133515260210 TABLET in 1 BOTTLE (71335-1526-2)Marketed from Feb 27, 2020
71335-1526-37133515260390 TABLET in 1 BOTTLE (71335-1526-3)Marketed from Dec 21, 2022
71335-1526-47133515260440 TABLET in 1 BOTTLE (71335-1526-4)Marketed from Dec 21, 2022

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
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200161
Marketing start
Listing expires
Other FDA classes
Aromatase Inhibitors (Mechanism)
Identifiers
Product ID 71335-1526_f187c05f-b55e-47f9-9c42-ee3640d28bfdSPL ID f187c05f-b55e-47f9-9c42-ee3640d28bfdSPL set ID 3cc750a5-cc88-4b42-b4ab-a87e760f291dRxCUI 200064UNII 7LKK855W8I
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

N471335152601 followed by a unit qualifier and the quantity

Package 71335-1526-01. 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 tablets are 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 ind…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200161

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

FDA NDC Directory listings under ANDA 200161
ProductStrengthForm · routeLabelerProduct NDC
LetrozoleLetrozole 2.5 mg/1TabletOralAvPAK50268-476
LetrozoleLetrozole 2.5 mg/1TabletOralBreckenridge Pharmaceutical, Inc.51991-759
LetrozoleLetrozole 2.5 mg/1TabletOralNatco Pharma Limited63850-0025
LetrozoleLetrozole 2.5 mg/1TabletOralA-S Medication Solutions50090-8002

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