Prescription drug · ANDA
Anastrozole (Anastrozole tablets) NDC 69117-0003
Anastrozole 1 mg/1 · Tablet · Oral · Yiling Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69117-0003-1 | 6911700030169117000301 | 30 TABLET in 1 BOTTLE (69117-0003-1)Marketed from Feb 28, 2019 | |
| 69117-0003-4 | 6911700030469117000304 | 1000 TABLET in 1 BOTTLE (69117-0003-4)Marketed from Feb 28, 2019 |
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 tablets
- Active ingredients
- Anastrozole — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Yiling Pharmaceutical, Inc.NDC labeler code 69117
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206037
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 69117-0003_4721ce01-03c8-f2d8-e063-6394a90ac3b6SPL ID 4721ce01-03c8-f2d8-e063-6394a90ac3b6SPL set ID 7b3da447-8e7c-2aaa-e053-2a91aa0a2821RxCUI 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
N469117000301followed by a unit qualifier and the quantityPackage 69117-0003-01. 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 is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breas…
Excerpt only. Read the full label for complete information.
About NDC 69117-0003
- What is NDC 69117-0003?
- 69117-0003 is the product NDC for Anastrozole (anastrozole tablets), Anastrozole 1 mg/1 tablet, listed with the FDA by Yiling Pharmaceutical, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Anastrozole (Anastrozole Tablets).
- What is the active ingredient?
- Anastrozole.
- Who is the labeler?
- Yiling Pharmaceutical, Inc., NDC labeler code 69117. 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.
Related NDCs: other Anastrozole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Direct_Rx | 72189-682 | 72189-0682-30 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-575 | 72789-0575-1572789-0575-30 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-725 | 24979-0725-0624979-0725-07 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | AvKARE | 42291-016 | 42291-0016-3042291-0016-90 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Direct_Rx | 72189-415 | 72189-0415-30 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-236 | 59651-0236-3059651-0236-90 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-085 | 42291-0085-3042291-0085-90 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | AvPAK | 50268-075 | 50268-0075-15 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Avet Pharmaceuticals Inc | 23155-857 | 23155-0857-0323155-0857-0523155-0857-09 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-490 | 62135-0490-3062135-0490-90 |
Other NDCs under ANDA 206037
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Avet Pharmaceuticals Inc | 23155-857 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-725 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-490 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3999 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Direct_Rx | 72189-682 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Proficient Rx LP | 82804-162 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-224 |