NDC codes

FDA NDC Directory
Product NDC (as listed)0093-7474Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-7474Add 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
0093-7474-890009374748900093747489120 TABLET, FILM COATED in 1 BOTTLE (0093-7474-89)Marketed from Mar 7, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Capecitabine
Generic name (nonproprietary)
capecitabine
Active ingredients
Capecitabine — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091649
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 0093-7474_94cd2146-70ff-43e3-a896-b9e55d75540fSPL ID 94cd2146-70ff-43e3-a896-b9e55d75540fSPL set ID 5753679a-506c-4ac4-b8b2-b27c664d1d40RxCUI 200327, 200328UNII 6804DJ8Z9U
Pharmacologic class
Nucleoside Metabolic 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

N400093747489 followed by a unit qualifier and the quantity

Package 00093-7474-89. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. ( 1.1 ) treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. ( 1.2 ) treatment of patients with ad…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-7474

What is NDC 0093-7474?
0093-7474 is the product NDC for Capecitabine, Capecitabine 500 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Capecitabine.
What is the active ingredient?
Capecitabine.
Who is the labeler?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Capecitabine?
30 other product NDCs are listed under this name. See all Capecitabine 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 Capecitabine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralCivicaScript LLC82249-20782249-0207-60
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralCivicaScript LLC82249-21082249-0210-12
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-64468001-0644-07
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-64368001-0643-06
capecitabineCapecitabine 500 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-30372603-0303-01
capecitabineCapecitabine 150 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-77431722-0774-60
capecitabineCapecitabine 500 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-77531722-0775-1231722-0775-60
CapecitabineCapecitabine 500 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-11282009-0112-12
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralCipla USA Inc.69097-94869097-0948-08
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralCipla USA Inc.69097-94969097-0949-03

All 31 Capecitabine NDCs

Other NDCs under ANDA 091649

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

FDA NDC Directory listings under ANDA 091649
ProductStrengthForm · routeLabelerProduct NDC
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-7473
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-639
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-640
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-149

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