What is NDC 76282-115?

76282-115 is the product NDC for Lamivudine and Zidovudine, Lamivudine 150 mg/1; Zidovudine 300 mg/1 tablet, film coated, listed with the FDA by Exelan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Exelan Pharmaceuticals Inc., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lamivudine and Zidovudine?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lamivudine and Zidovudine NDC 76282-115

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0115Add 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
76282-115-05	7628201150576282011505	500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05)Marketed from Apr 29, 2015
76282-115-60	7628201156076282011560	60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60)Marketed from Apr 29, 2015

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): Lamivudine and Zidovudine
Generic name (nonproprietary): lamivudine and zidovudine
Active ingredients: Lamivudine — 150 mg/1Zidovudine — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Exelan Pharmaceuticals Inc.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203259
Marketing start: Apr 29, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 76282-115_9d9239ba-eadd-45f3-a528-f9e2f7e2db04SPL ID 9d9239ba-eadd-45f3-a528-f9e2f7e2db04SPL set ID 4cf565c3-bdec-4c18-93c1-cc7fa8331c90RxCUI 200082UNII 2T8Q726O95, 4B9XT59T7SUPC 0376282115603
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

N476282011505 followed by a unit qualifier and the quantity

Package 76282-0115-05. 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 1, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

Lamivudine and Zidovudine Tablet, USP a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection. Lamivudine and Zidovudine Tablets USP, a combination of two nucleoside analogue 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 76282-115

What is NDC 76282-115?: 76282-115 is the product NDC for Lamivudine and Zidovudine, Lamivudine 150 mg/1; Zidovudine 300 mg/1 tablet, film coated, listed with the FDA by Exelan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lamivudine and Zidovudine.
What is the active ingredient?: Lamivudine, Zidovudine.
Who is the labeler?: Exelan Pharmaceuticals Inc., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lamivudine and Zidovudine?: 7 other product NDCs are listed under this name. See all Lamivudine and Zidovudine 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 Lamivudine and Zidovudine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lamivudine And Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals, Inc	72865-144	72865-0144-60
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-003	33342-0003-09
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	TabletOral	Bryant Ranch Prepack	71335-1916	71335-1916-0171335-1916-0271335-1916-03
LAMIVUDINE and ZIDOVUDINE	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-506	31722-0506-0531722-0506-60
LAMIVUDINE and ZIDOVUDINE	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-900	43063-0900-06
LAMIVUDINE and ZIDOVUDINE	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0639	71335-0639-0171335-0639-0271335-0639-03
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-739	31722-0739-0531722-0739-3131722-0739-60

Other NDCs under ANDA 203259

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

FDA NDC Directory listings under ANDA 203259
Product	Strength	Form · route	Labeler	Product NDC
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-739
Lamivudine And Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals, Inc	72865-144