What is NDC 69097-362?

69097-362 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 Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-362 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-362Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0362Add 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
69097-362-02	69097036202	30 TABLET, FILM COATED in 1 BOTTLE (69097-362-02)Marketed from Mar 29, 2017

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: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091144
Marketing start: Mar 28, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 69097-362_1a48f22b-e37b-4221-9f99-a9e149279630SPL ID 1a48f22b-e37b-4221-9f99-a9e149279630SPL set ID c0488bee-2f18-4e2e-8e11-68543c023decRxCUI 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

N469097036202 followed by a unit qualifier and the quantity

Package 69097-0362-02. 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 Jan 18, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-362

What is NDC 69097-362?: 69097-362 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 Cipla USA Inc.. It has 1 package NDC, 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?: Cipla USA Inc., NDC labeler code 69097. 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	Aurobindo Pharma Limited	65862-335	65862-0335-1065862-0335-30
Abacavir and Lamivudine	Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-288	—