What is NDC 33342-001?

33342-001 is the product NDC for Lamivudine, Lamivudine 150 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?

25 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lamivudine NDC 33342-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0001Add 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
33342-001-09	33342000109	60 TABLET, FILM COATED in 1 BOTTLE (33342-001-09)Marketed from May 2, 2019

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
Generic name (nonproprietary): lamivudine
Active ingredients: Lamivudine — 150 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090198
Marketing start: May 2, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 33342-001_9e19f010-5f8a-4582-8d49-c385698d9996SPL ID 9e19f010-5f8a-4582-8d49-c385698d9996SPL set ID 1be30bcc-2d9f-4afc-8f09-adc840b3f2d9RxCUI 199147, 349491UNII 2T8Q726O95UPC 0333342001092, 0333342002075
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

N433342000109 followed by a unit qualifier and the quantity

Package 33342-0001-09. 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 1, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: • The dosage of this product is for HIV-1 and not for HBV. Lamivudine is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-001

What is NDC 33342-001?: 33342-001 is the product NDC for Lamivudine, Lamivudine 150 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lamivudine.
What is the active ingredient?: Lamivudine.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?: 25 other product NDCs are listed under this name. See all 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 Lamivudine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lamivudine	Lamivudine 150 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1459	67046-1459-03
Lamivudine	Lamivudine 150 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-720	60687-0720-21
Lamivudine	Lamivudine 300 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-002	33342-0002-07
lamivudine	Lamivudine 100 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-001	31722-0001-0231722-0001-60
Lamivudine	Lamivudine 150 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-710	64380-0710-03
Lamivudine	Lamivudine 300 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-711	64380-0711-04
Lamivudine	Lamivudine 150 mg/1	TabletOral	Ingenus Pharmaceuticals, LLC	50742-623	50742-0623-60
Lamivudine	Lamivudine 300 mg/1	TabletOral	Ingenus Pharmaceuticals, LLC	50742-624	50742-0624-60
Lamivudine	Lamivudine 10 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-274	57237-0274-24
Lamivudine	Lamivudine 150 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-025	65862-0025-1065862-0025-60

All 26 Lamivudine NDCs

Other NDCs under ANDA 090198

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

FDA NDC Directory listings under ANDA 090198
Product	Strength	Form · route	Labeler	Product NDC
Lamivudine	Lamivudine 300 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-002