NDC codes

FDA NDC Directory
Product NDC (as listed)42385-962Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42385-0962Add 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
42385-962-184238509621842385096218180 TABLET, FILM COATED in 1 BOTTLE (42385-962-18)Marketed from Jul 25, 2022
42385-962-30423850962304238509623030 TABLET, FILM COATED in 1 BOTTLE (42385-962-30)Marketed from Jul 25, 2022
42385-962-90423850962904238509629090 TABLET, FILM COATED in 1 BOTTLE (42385-962-90)Marketed from Jul 25, 2022

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
Laurus Labs LimitedNDC labeler code 42385
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216332
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 42385-962_6ce5a446-f6a1-4efe-8a69-fd6ddf1a8ab2SPL ID 6ce5a446-f6a1-4efe-8a69-fd6ddf1a8ab2
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

N442385096218 followed by a unit qualifier and the quantity

Package 42385-0962-18. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 42385-962

What is NDC 42385-962?
42385-962 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 Laurus Labs Limited. It has 3 package NDCs, 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?
Laurus Labs Limited, NDC labeler code 42385. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ABACAVIR and LAMIVUDINEAbacavir sulfate 600 mg/1; Lamivudine 300 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-83831722-0838-30
Abacavir and LamivudineAbacavir sulfate 600 mg/1; Lamivudine 300 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-44033342-0440-0733342-0440-1433342-0440-98
Abacavir and LamivudineAbacavir sulfate 600 mg/1; Lamivudine 300 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-33565862-0335-1065862-0335-30
Abacavir and LamivudineAbacavir sulfate 600 mg/1; Lamivudine 300 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-288—
Abacavir and LamivudineAbacavir sulfate 600 mg/1; Lamivudine 300 mg/1Tablet, Film coatedOralCipla USA Inc.69097-36269097-0362-02

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