What is NDC 55111-646?

55111-646 is the product NDC for Letrozole, Letrozole 2.5 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Letrozole NDC 55111-646 | National Drug Code

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	5511106463055111064630	30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30)Marketed from Jun 3, 2011
55111-646-78	5511106467855111064678	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 LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091191
Marketing start: Jun 3, 2011
Listing expires: Dec 31, 2027
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)

About NDC 55111-646

What is NDC 55111-646?: 55111-646 is the product NDC for Letrozole, Letrozole 2.5 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, 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?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Letrozole	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Carnegie Pharmaceuticals LLC	80005-139	80005-0139-0880005-0139-10
Letrozoleletrozole tablets	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Upsher-Smith Laboratories, LLC	24979-726	24979-0726-07
Letrozoleletrozole tablets	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Avet Pharmaceuticals Inc.	23155-875	23155-0875-0323155-0875-0923155-0875-10
Letrozoleletrozole tablets	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2396	71335-2396-0171335-2396-0271335-2396-03+1 more
Letrozole	Letrozole 2.5 mg/1	Tablet, Film coatedOral	ATLANTIC BIOLOGICALS CORP.	17856-0032	17856-0032-01
Letrozole	Letrozole 2.5 mg/1	TabletOral	AvPAK	50268-476	50268-0476-15
Letrozoleletrozole tablets	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Yiling Pharmaceutical, Inc.	69117-0004	69117-0004-01
Letrozole	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-491	62135-0491-3062135-0491-90
Letrozole	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-180	59651-0180-3059651-0180-90
Letrozoleletrozole tablets	Letrozole 2.5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-986	51407-0986-90

All 23 Letrozole NDCs

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