NDC codes

FDA NDC Directory
Product NDC (as listed)63629-5269Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-5269Add 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
63629-5269-0636295269006362952690028 TABLET in 1 BOTTLE, PLASTIC (63629-5269-0)Marketed from Jan 5, 2021
63629-5269-1636295269016362952690130 TABLET in 1 BOTTLE (63629-5269-1)Marketed from Mar 21, 2014
63629-5269-2636295269026362952690220 TABLET in 1 BOTTLE (63629-5269-2)Marketed from Aug 13, 2014
63629-5269-3636295269036362952690390 TABLET in 1 BOTTLE (63629-5269-3)Marketed from Jan 26, 2016
63629-5269-463629526904636295269044 TABLET in 1 BOTTLE (63629-5269-4)Marketed from Jun 20, 2018
63629-5269-563629526905636295269056 TABLET in 1 BOTTLE (63629-5269-5)Marketed from Dec 1, 2021
63629-5269-6636295269066362952690610 TABLET in 1 BOTTLE (63629-5269-6)Marketed from Jun 25, 2018
63629-5269-7636295269076362952690740 TABLET in 1 BOTTLE (63629-5269-7)Marketed from Nov 20, 2019
63629-5269-8636295269086362952690812 TABLET in 1 BOTTLE (63629-5269-8)Marketed from Mar 6, 2019
63629-5269-9636295269096362952690914 TABLET in 1 BOTTLE (63629-5269-9)Marketed from Jul 7, 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)
Anastrozole
Generic name (nonproprietary)
anastrozole
Active ingredients
Anastrozole — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
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 63629-5269_8a570a78-9fc6-46eb-b8fd-bef140eef78eSPL ID 8a570a78-9fc6-46eb-b8fd-bef140eef78eSPL set ID 19251d0b-279a-49f5-99b2-0e74d7cca479RxCUI 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

N463629526900 followed by a unit qualifier and the quantity

Package 63629-5269-00. 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 63629-5269

What is NDC 63629-5269?
63629-5269 is the product NDC for Anastrozole, Anastrozole 1 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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/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
AnastrozoleAnastrozole 1 mg/1TabletOralAsclemed USA, Inc.76420-004

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