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NDC 69097-0948-08 Capecitabine 500 mg/1 Details
Capecitabine 500 mg/1
Capecitabine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is CAPECITABINE.
MedlinePlus Drug Summary
Capecitabine is used in combination with other medications to treat breast cancer that has come back after treatment with other medications. It is also used alone to treat breast cancer that has not improved after treatment with other medications. Capecitabine is also used to treat colon or rectal cancer (cancer that begins in the large intestine) that has gotten worse or spread to other parts of the body. It is also used to prevent colon cancer from spreading in people who have had surgery to remove the tumor. Capecitabine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells.
Related Packages: 69097-0948-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capecitabine
Product Information
| NDC | 69097-0948 |
|---|---|
| Product ID | 69097-948_c1549b67-948e-402d-9ba4-6fc16237df8f |
| Associated GPIs | 21300005000350 |
| GCN Sequence Number | 039781 |
| GCN Sequence Number Description | capecitabine TABLET 500 MG ORAL |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 31612 |
| HICL Sequence Number | 018385 |
| HICL Sequence Number Description | CAPECITABINE |
| Brand/Generic | Generic |
| Proprietary Name | Capecitabine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Capecitabine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | CAPECITABINE |
| Labeler Name | Cipla USA Inc. |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209365 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69097-0948-08 (69097094808)
| NDC Package Code | 69097-948-08 |
|---|---|
| Billing NDC | 69097094808 |
| Package | 120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08) |
| Marketing Start Date | 2023-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.66313 |
| Pricing Unit | EA |
| Effective Date | 2022-10-19 |
| NDC Description | CAPECITABINE 500 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |