Clopidogrel NDC 16714-052

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-052Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0052Add 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
16714-052-01	16714005201	30 TABLET in 1 BOTTLE (16714-052-01)Marketed from Aug 9, 2022
16714-052-02	16714005202	90 TABLET in 1 BOTTLE (16714-052-02)Marketed from Aug 9, 2022
16714-052-03	16714005203	500 TABLET in 1 BOTTLE (16714-052-03)Marketed from Aug 9, 2022
16714-052-04	16714005204	1000 TABLET in 1 BOTTLE (16714-052-04)Marketed from Apr 25, 2023
16714-052-10	16714005210	10 TABLET in 1 BLISTER PACK (16714-052-10)Marketed from Aug 9, 2022
16714-052-11	16714005211	100 TABLET in 1 BOX, UNIT-DOSE (16714-052-11)Marketed from Aug 9, 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
Generic name (nonproprietary): clopidogrel
Active ingredients: Clopidogrel bisulfate — 75 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NorthStar RxLLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202928
Marketing start: Aug 9, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers: Product ID 16714-052_dbf6d86e-5d4f-40da-a933-b928843053b7SPL ID dbf6d86e-5d4f-40da-a933-b928843053b7SPL set ID d176de1d-b1b3-4aa9-b783-d53f65a79e50RxCUI 309362UNII 08I79HTP27UPC 0316714052014, 0316714052021, 0316714052045, 0316714052038
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

N416714005201 followed by a unit qualifier and the quantity

Package 16714-0052-01. 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 Nov 21, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Clopidogrel is 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 has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1 ) • Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) • Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and strok…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202928

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

FDA NDC Directory listings under ANDA 202928
Product	Strength	Form · route	Labeler	Product NDC
Clopidogrel	Clopidogrel bisulfate 75 mg/1	TabletOral	Bryant Ranch Prepack	71335-0581
Clopidogrel	Clopidogrel bisulfate 75 mg/1	TabletOral	Redpharm Drug	67296-2266
Clopidogrel	Clopidogrel bisulfate 75 mg/1	TabletOral	A-S Medication Solutions	50090-6568
Clopidogrel	Clopidogrel bisulfate 75 mg/1	TabletOral	A-S Medication Solutions	50090-6567
Clopidogrel	Clopidogrel bisulfate 75 mg/1	TabletOral	A-S Medication Solutions	50090-5781
Clopidogrel	Clopidogrel bisulfate 75 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-060