NDC codes

FDA NDC Directory
Product NDC (as listed)43063-371Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0371Add 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
43063-371-30430630371304306303713030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-30)Marketed from Jul 23, 2012
43063-371-60430630371604306303716060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-60)Marketed from Jul 23, 2012
43063-371-90430630371904306303719090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-90)Marketed from Jul 23, 2012

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)
Clopidogrel Bisulfate
Generic name (nonproprietary)
clopidogrel bisulfate
Active ingredients
Clopidogrel bisulfate — 75 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090844
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers
Product ID 43063-371_2f2711fd-44b7-517f-e063-6294a90a0982SPL ID 2f2711fd-44b7-517f-e063-6294a90a0982SPL set ID 03bec9ad-cd22-44d3-9b82-2796157de1d1RxCUI 309362UNII 08I79HTP27UPC 0343063371909
Pharmacologic class
P2Y12 Platelet 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

N443063037130 followed by a unit qualifier and the quantity

Package 43063-0371-30. 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)

Clopidogrel tablets are P2Y 12 platelet inhibitor indicated for: ● Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.1 ) ● Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-371

What is NDC 43063-371?
43063-371 is the product NDC for Clopidogrel Bisulfate, Clopidogrel bisulfate 75 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clopidogrel Bisulfate.
What is the active ingredient?
Clopidogrel bisulfate.
Who is the labeler?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clopidogrel Bisulfate?
21 other product NDCs are listed under this name. See all Clopidogrel Bisulfate 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 Clopidogrel Bisulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clopidogrel BisulfateClopidogrel bisulfate 75 mg/1TabletOralRising Pharma Holdings, Inc.64980-71364980-0713-0364980-0713-0964980-0713-50
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-468070518-4680-00
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-18282009-0182-05
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralDr.Reddy's Laboratories Inc43598-12143598-0121-0543598-0121-1043598-0121-30+1 more
Clopidogrel bisulfateClopidogrel bisulfate 300 mg/1Tablet, Film coatedOralDr.Reddy's Laboratories Inc43598-12243598-0122-0543598-0122-3043598-0122-59
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-411070518-4110-0070518-4110-0170518-4110-02+2 more
Clopidogrel bisulfateClopidogrel bisulfate 300 mg/1Tablet, Film coatedOralRADHA PHARMACEUTICALS, INC.77771-12177771-0121-0577771-0121-3077771-0121-90
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralRADHA PHARMACEUTICALS, INC.77771-12477771-0124-1077771-0124-3077771-0124-90
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-02182009-0021-05
Clopidogrel bisulfateClopidogrel bisulfate 300 mg/1Tablet, Film coatedOralMcKesson Corporation dba SKY Packaging63739-17863739-0178-30

All 22 Clopidogrel Bisulfate NDCs

Other NDCs under ANDA 090844

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

FDA NDC Directory listings under ANDA 090844
ProductStrengthForm · routeLabelerProduct NDC
ClopidogrelClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-141

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