What is NDC 65862-335?

65862-335 is the product NDC for Abacavir and Lamivudine, Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Abacavir and Lamivudine?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Abacavir and Lamivudine NDC 65862-335

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-335Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0335Add 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
65862-335-10	6586203351065862033510	10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 15, 2018
65862-335-30	6586203353065862033530	1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 15, 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 and Lamivudine
Generic name (nonproprietary): abacavir and lamivudine
Active ingredients: Abacavir sulfate — 600 mg/1Lamivudine — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090159
Marketing start: Nov 15, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 65862-335_7fbb109d-29d0-4439-b4ef-00c587cc6099SPL ID 7fbb109d-29d0-4439-b4ef-00c587cc6099SPL set ID deda1a24-2f51-4601-9881-347f47270940RxCUI 602393UNII J220T4J9Q2, 2T8Q726O95
Pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; 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

N465862033510 followed by a unit qualifier and the quantity

Package 65862-0335-10. 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 19, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, are 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)

About NDC 65862-335

What is NDC 65862-335?: 65862-335 is the product NDC for Abacavir and Lamivudine, Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Abacavir and Lamivudine.
What is the active ingredient?: Abacavir sulfate, Lamivudine.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Abacavir and Lamivudine?: 5 other product NDCs are listed under this name. See all Abacavir and Lamivudine 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 Abacavir and Lamivudine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
ABACAVIR and LAMIVUDINE	Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-838	31722-0838-30
Abacavir and Lamivudine	Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-440	33342-0440-0733342-0440-1433342-0440-98
Abacavir and Lamivudine	Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-962	42385-0962-1842385-0962-3042385-0962-90
Abacavir and Lamivudine	Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-288	—
Abacavir and Lamivudine	Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-362	69097-0362-02