What is NDC 83634-301?

83634-301 is the product NDC for Eptifibatide, Eptifibatide .75 mg/mL injection, solution, listed with the FDA by Avenacy, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Avenacy, LLC, NDC labeler code 83634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Eptifibatide?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Eptifibatide NDC 83634-301 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83634-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83634-0301Add 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
83634-301-51	8363403015183634030151	1 VIAL, SINGLE-DOSE in 1 CARTON (83634-301-51) / 100 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 31, 2024

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): Eptifibatide
Generic name (nonproprietary): eptifibatide
Active ingredients: Eptifibatide — .75 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Avenacy, LLCNDC labeler code 83634
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213081
Marketing start: Jan 31, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Platelet Aggregation (Physiologic effect)
Identifiers: Product ID 83634-301_f38e5635-9cbd-47d6-8a65-10411b6399ccSPL ID f38e5635-9cbd-47d6-8a65-10411b6399cc
Pharmacologic class: Platelet Aggregation 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N483634030151 followed by a unit qualifier and the quantity

Package 83634-0301-51. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 83634-301

What is NDC 83634-301?: 83634-301 is the product NDC for Eptifibatide, Eptifibatide .75 mg/mL injection, solution, listed with the FDA by Avenacy, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Eptifibatide.
What is the active ingredient?: Eptifibatide.
Who is the labeler?: Avenacy, LLC, NDC labeler code 83634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eptifibatide?: 20 other product NDCs are listed under this name. See all Eptifibatide 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 Eptifibatide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Eptifibatide	Eptifibatide 2 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-412	71288-0412-10
Eptifibatide	Eptifibatide .75 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-413	71288-0413-51
Eptifibatide	Eptifibatide 2 mg/mL	Injection, SolutionIntravenous	Avenacy, LLC	83634-300	83634-0300-10
Eptifibatide	Eptifibatide .75 mg/mL	Injection, SolutionIntravenous	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-040	52958-0040-01
Eptifibatide	Eptifibatide 2 mg/mL	Injection, SolutionIntravenous	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-402	52958-0402-01
Eptifibatide	Eptifibatide 2 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-025	72078-0025-10
Eptifibatide	Eptifibatide 2 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-027	72078-0027-10
Eptifibatide	Eptifibatide .75 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-026	72078-0026-10
Eptifibatide	Eptifibatide 2 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-026	70436-0026-80
Eptifibatide	Eptifibatide .75 mg/mL	InjectionIntravenous	Slate Run Pharmaceuticals, LLC	70436-027	70436-0027-80

All 21 Eptifibatide NDCs

Other NDCs under ANDA 213081

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

FDA NDC Directory listings under ANDA 213081
Product	Strength	Form · route	Labeler	Product NDC
Eptifibatide	Eptifibatide .75 mg/mL	Injection, SolutionIntravenous	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-040
Eptifibatide	Eptifibatide 2 mg/mL	Injection, SolutionIntravenous	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-402
Eptifibatide	Eptifibatide 2 mg/mL	Injection, SolutionIntravenous	Avenacy, LLC	83634-300