NDC codes

FDA NDC Directory
Product NDC (as listed)16729-035Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0035Add 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
16729-035-10167290035101672900351030 TABLET in 1 BOTTLE, PLASTIC (16729-035-10)Marketed from Jun 22, 2010
16729-035-15167290035151672900351590 TABLET in 1 BOTTLE, PLASTIC (16729-035-15)Marketed from Feb 24, 2011
16729-035-161672900351616729003516500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16)Marketed from Mar 21, 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)
Anastrozole
Generic name (nonproprietary)
anastrozole
Active ingredients
Anastrozole — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Accord Healthcare Inc.NDC labeler code 16729
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 16729-035_4a900d2c-12d3-6bfa-e063-6294a90af009SPL ID 4a900d2c-12d3-6bfa-e063-6294a90af009SPL set ID 03586c40-eb32-45c5-beb7-6762a6b78790RxCUI 199224UNII 2Z07MYW1AZUPC 0316729035101
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

N416729003510 followed by a unit qualifier and the quantity

Package 16729-0035-10. 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 16729-035

What is NDC 16729-035?
16729-035 is the product NDC for Anastrozole, Anastrozole 1 mg/1 tablet, listed with the FDA by Accord Healthcare Inc.. It has 3 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?
Accord Healthcare Inc., NDC labeler code 16729. 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/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
AnastrozoleAnastrozole 1 mg/1TabletOralAsclemed USA, Inc.76420-004

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