Letrozole NDC 55111-646

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-646Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0646Add 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 NDC	11-digit (billing)	Package	Copy
55111-646-30	55111064630	30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30)Marketed from Jun 3, 2011
55111-646-78	55111064678	10 BLISTER PACK in 1 CARTON (55111-646-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79)Marketed from Jun 3, 2011

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): Letrozole
Generic name (nonproprietary): letrozole
Active ingredients: Letrozole — 2.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091191
Marketing start: Jun 3, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Aromatase Inhibitors (Mechanism)
Identifiers: Product ID 55111-646_ec1b249b-2d77-55d9-0520-23884a961cf0SPL ID ec1b249b-2d77-55d9-0520-23884a961cf0SPL set ID 6cfd29d7-f519-7b8c-4814-07b39f367f0dRxCUI 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

N455111064630 followed by a unit qualifier and the quantity

Package 55111-0646-30. 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 Dec 6, 2018.

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 indicated …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091191

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

FDA NDC Directory listings under ANDA 091191
Product	Strength	Form · route	Labeler	Product NDC
Letrozole	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Carnegie Pharmaceuticals LLC	80005-139