What is NDC 69097-514?

69097-514 is the product NDC for Abacavir, Abacavir sulfate 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?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Abacavir NDC 69097-514 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0514Add 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
69097-514-03	6909705140369097051403	60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)Marketed from Nov 21, 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
Generic name (nonproprietary): abacavir
Active ingredients: Abacavir sulfate — 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 078119
Marketing start: Nov 21, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 69097-514_cf84089d-b713-40b8-a815-b66f4119982eSPL ID cf84089d-b713-40b8-a815-b66f4119982eSPL set ID 0d791375-e311-41f9-87b8-940657e6318cRxCUI 242679UNII J220T4J9Q2
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

N469097051403 followed by a unit qualifier and the quantity

Package 69097-0514-03. 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 Dec 24, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Abacavir tablet, 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. Abacavir tablets USP 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-514

What is NDC 69097-514?: 69097-514 is the product NDC for Abacavir, Abacavir sulfate 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.
What is the active ingredient?: Abacavir sulfate.
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?: 9 other product NDCs are listed under this name. See all Abacavir 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Abacavir	Abacavir sulfate 300 mg/1	TabletOral	XLCare Pharmaceuticals Inc.	72865-167	72865-0167-60
Abacavir	Abacavir sulfate 300 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-557	31722-0557-60
Abacavir	Abacavir sulfate 300 mg/1	TabletOral	Coupler LLC	67046-1602	67046-1602-03
Abacavir	Abacavir sulfate 300 mg/1	TabletOral	AvPAK	50268-049	50268-0049-12
Abacavirabacavir sulfate	Abacavir sulfate 20 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	64980-405	64980-0405-24
Abacavirabacavir sulfate	Abacavir sulfate 20 mg/mL	SolutionOral	Aurobindo Pharma Limited	65862-089	65862-0089-24
Abacavir	Abacavir sulfate 20 mg/mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-562	31722-0562-24
Abacavir	Abacavir sulfate 300 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-021	68084-0021-21
Abacavir	Abacavir sulfate 300 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6874	00904-6874-0400904-6874-06