NDC codes

FDA NDC Directory
Product NDC (as listed)57237-274Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0274Add 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 NDC11-digit (billing)PackageCopy
57237-274-2457237027424240 mL in 1 BOTTLE (57237-274-24)Marketed from Nov 21, 2016

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 — 10 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077695
Marketing start
Listing expires
Other FDA classes
Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 57237-274_413db889-6bea-4815-b016-d619dba8029fSPL ID 413db889-6bea-4815-b016-d619dba8029fSPL set ID bed2e227-8d36-40ea-bbbf-d8793bfda425RxCUI 199148UNII 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

N457237027424 followed by a unit qualifier and the quantity

Package 57237-0274-24. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Lamivudine oral solution is a 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 oral solution 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 57237-274

What is NDC 57237-274?
57237-274 is the product NDC for Lamivudine, Lamivudine 10 mg/mL solution, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
Rising Pharma Holdings, Inc., NDC labeler code 57237. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LamivudineLamivudine 150 mg/1Tablet, Film coatedOralCoupler LLC67046-145967046-1459-03
LamivudineLamivudine 150 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-72060687-0720-21
LamivudineLamivudine 150 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-00133342-0001-09
LamivudineLamivudine 300 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-00233342-0002-07
lamivudineLamivudine 100 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-00131722-0001-0231722-0001-60
LamivudineLamivudine 300 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-71164380-0711-04
LamivudineLamivudine 150 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-71064380-0710-03
LamivudineLamivudine 150 mg/1TabletOralIngenus Pharmaceuticals, LLC50742-62350742-0623-60
LamivudineLamivudine 300 mg/1TabletOralIngenus Pharmaceuticals, LLC50742-62450742-0624-60
LamivudineLamivudine 300 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-02665862-0026-1065862-0026-30

All 26 Lamivudine NDCs

Other NDCs under ANDA 077695

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

FDA NDC Directory listings under ANDA 077695
ProductStrengthForm · routeLabelerProduct NDC
LamivudineLamivudine 10 mg/mLSolutionOralAurobindo Pharma Limited65862-055

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