NDC codes

FDA NDC Directory
Product NDC (as listed)76420-004Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0004Add 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
76420-004-127642000041276420000412120 TABLET in 1 BOTTLE, PLASTIC (76420-004-12)Marketed from Dec 24, 2019
76420-004-157642000041576420000415150 TABLET in 1 BOTTLE, PLASTIC (76420-004-15)Marketed from Dec 24, 2019
76420-004-20764200004207642000042020 TABLET in 1 BOTTLE, PLASTIC (76420-004-20)Marketed from Dec 24, 2019
76420-004-30764200004307642000043030 TABLET in 1 BOTTLE, PLASTIC (76420-004-30)Marketed from Dec 24, 2019

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)
Anastrozole
Generic name (nonproprietary)
anastrozole
Active ingredients
Anastrozole — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Asclemed USA, Inc.NDC labeler code 76420
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090568
Marketing start
Listing expires
Other FDA classes
Aromatase Inhibitors (Mechanism)
Identifiers
Product ID 76420-004_4ad5b64f-c4f3-4aa0-e063-6394a90a8a21SPL ID 4ad5b64f-c4f3-4aa0-e063-6394a90a8a21SPL set ID b964f555-25d2-47ad-8942-f195f062445cRxCUI 199224UNII 2Z07MYW1AZ
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

N476420000412 followed by a unit qualifier and the quantity

Package 76420-0004-12. 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)

Anastrozole is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2 ) Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole ( 1.3 ) 1.1 Adjuvant Treatment Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive ea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-004

What is NDC 76420-004?
76420-004 is the product NDC for Anastrozole, Anastrozole 1 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Anastrozole.
What is the active ingredient?
Anastrozole.
Who is the labeler?
Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Anastrozole?
38 other product NDCs are listed under this name. See all Anastrozole 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 Anastrozole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AnastrozoleAnastrozole 1 mg/1TabletOralDirect_Rx72189-68272189-0682-30
AnastrozoleAnastrozole 1 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-57572789-0575-1572789-0575-30
Anastrozoleanastrozole tabletsAnastrozole 1 mg/1TabletOralUpsher-Smith Laboratories, LLC24979-72524979-0725-0624979-0725-07
AnastrozoleAnastrozole 1 mg/1TabletOralAvKARE42291-01642291-0016-3042291-0016-90
AnastrozoleAnastrozole 1 mg/1TabletOralDirect_Rx72189-41572189-0415-30
AnastrozoleAnastrozole 1 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-23659651-0236-3059651-0236-90
AnastrozoleAnastrozole 1 mg/1Tablet, Film coatedOralAvKARE42291-08542291-0085-3042291-0085-90
AnastrozoleAnastrozole 1 mg/1TabletOralAvPAK50268-07550268-0075-15
Anastrozoleanastrozole tabletsAnastrozole 1 mg/1TabletOralAvet Pharmaceuticals Inc23155-85723155-0857-0323155-0857-0523155-0857-09
AnastrozoleAnastrozole 1 mg/1TabletOralChartwell RX, LLC62135-49062135-0490-3062135-0490-90

All 39 Anastrozole NDCs

Other NDCs under ANDA 090568

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

FDA NDC Directory listings under ANDA 090568
ProductStrengthForm · routeLabelerProduct NDC
AnastrozoleAnastrozole 1 mg/1TabletOralAccord Healthcare Inc.16729-035
AnastrozoleAnastrozole 1 mg/1TabletOralA-S Medication Solutions50090-2453
AnastrozoleAnastrozole 1 mg/1TabletOralProficient Rx LP63187-080
AnastrozoleAnastrozole 1 mg/1TabletOralBryant Ranch Prepack63629-5269
AnastrozoleAnastrozole 1 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-1543
AnastrozoleAnastrozole 1 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-1682
AnastrozoleAnastrozole 1 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2791
AnastrozoleAnastrozole 1 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5203
AnastrozoleAnastrozole 1 mg/1TabletOralDirect_Rx72189-415
AnastrozoleAnastrozole 1 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-008

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