What is NDC 82009-021?

82009-021 is the product NDC for Clopidogrel bisulfate, Clopidogrel bisulfate 75 mg/1 tablet, film coated, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clopidogrel bisulfate NDC 82009-021

NDC codes

FDA NDC Directory

Product NDC (as listed)82009-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82009-0021Add 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 NDC	11-digit (billing)	Package	Copy
82009-021-05	8200900210582009002105	500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05)Marketed from Nov 15, 2022

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: Quallent Pharmaceuticals Health LLCNDC labeler code 82009
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076273
Marketing start: Nov 15, 2022
Marketing end: Feb 28, 2027
Other FDA classes: Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers: Product ID 82009-021_e8fadba0-80b2-f6fd-ba68-512d796e5d89SPL ID e8fadba0-80b2-f6fd-ba68-512d796e5d89SPL set ID 333c7992-d481-b7d4-404f-9a49c85b6331RxCUI 309362UNII 08I79HTP27UPC 0382009021904
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

N482009002105 followed by a unit qualifier and the quantity

Package 82009-0021-05. 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 Oct 14, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Clopidogrel tablets are a 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 rate of myo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82009-021

What is NDC 82009-021?: 82009-021 is the product NDC for Clopidogrel bisulfate, Clopidogrel bisulfate 75 mg/1 tablet, film coated, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, 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?: Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clopidogrel Bisulfate	Clopidogrel bisulfate 75 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-713	64980-0713-0364980-0713-0964980-0713-50
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4680	70518-4680-00
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-182	82009-0182-05
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Dr.Reddy's Laboratories Inc	43598-121	43598-0121-0543598-0121-1043598-0121-30+1 more
Clopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	Dr.Reddy's Laboratories Inc	43598-122	43598-0122-0543598-0122-3043598-0122-59
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4110	70518-4110-0070518-4110-0170518-4110-02+2 more
Clopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	RADHA PHARMACEUTICALS, INC.	77771-121	77771-0121-0577771-0121-3077771-0121-90
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	RADHA PHARMACEUTICALS, INC.	77771-124	77771-0124-1077771-0124-3077771-0124-90
Clopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	McKesson Corporation dba SKY Packaging	63739-178	63739-0178-30
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-7700	68788-7700-0368788-7700-0668788-7700-09

All 22 Clopidogrel bisulfate NDCs

Other NDCs under ANDA 076273

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

FDA NDC Directory listings under ANDA 076273
Product	Strength	Form · route	Labeler	Product NDC
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Dr.Reddy's Laboratories Limited	55111-196