Abacavir (abacavir sulfate) NDC 65862-089

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-089Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0089Add 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
65862-089-24	65862008924	1 BOTTLE in 1 CARTON (65862-089-24) / 240 mL in 1 BOTTLEMarketed from Mar 14, 2018

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): Abacavir
Generic name (nonproprietary): abacavir sulfate
Active ingredients: Abacavir sulfate — 20 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077950
Marketing start: Mar 14, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 65862-089_e1bbcda5-e1ce-48d6-99d0-8545112b08c8SPL ID e1bbcda5-e1ce-48d6-99d0-8545112b08c8SPL set ID e2214976-657c-4018-b059-1ad66a7e2b6fRxCUI 242680UNII J220T4J9Q2UPC 0365862089243
Pharmacologic class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase 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

N465862008924 followed by a unit qualifier and the quantity

Package 65862-0089-24. 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 May 8, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Abacavir oral solution, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077950

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

FDA NDC Directory listings under ANDA 077950
Product	Strength	Form · route	Labeler	Product NDC
Abacavirabacavir sulfate	Abacavir sulfate 20 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	64980-405