What is NDC 42385-934?

42385-934 is the product NDC for Lopinavir and Ritonavir, Lopinavir 200 mg/1; Ritonavir 50 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Lopinavir and Ritonavir?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lopinavir and Ritonavir NDC 42385-934 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-934Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0934Add 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
42385-934-12	42385093412	120 TABLET, FILM COATED in 1 BOTTLE (42385-934-12)Marketed from Mar 22, 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): Lopinavir and Ritonavir
Generic name (nonproprietary): lopinavir and ritonavir
Active ingredients: Lopinavir — 200 mg/1Ritonavir — 50 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 213857
Marketing start: Mar 22, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UDP Glucuronosyltransferases Inducers (Mechanism)
Identifiers: Product ID 42385-934_3a3c4164-da47-427d-9f12-6d1f73b0729dSPL ID 3a3c4164-da47-427d-9f12-6d1f73b0729dSPL set ID a7072c60-6dbf-4125-95e7-497c05a9e6a6RxCUI 597730, 746645UNII 2494G1JF75, O3J8G9O825UPC 0342385933604
Pharmacologic class: Cytochrome P450 3A Inhibitor; Protease 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

N442385093412 followed by a unit qualifier and the quantity

Package 42385-0934-12. 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 Oct 20, 2023.

Indications (excerpt from the label)

Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV- 1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [ see Microbiology (12.4) ] . Lopinavir and ritonavir is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42385-934

What is NDC 42385-934?: 42385-934 is the product NDC for Lopinavir and Ritonavir, Lopinavir 200 mg/1; Ritonavir 50 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lopinavir and Ritonavir.
What is the active ingredient?: Lopinavir, Ritonavir.
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 Lopinavir and Ritonavir?: 5 other product NDCs are listed under this name. See all Lopinavir and Ritonavir 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 Lopinavir and Ritonavir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lopinavir and Ritonavir	Lopinavir 100 mg/1; Ritonavir 25 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-163	33342-0163-09
Lopinavir and Ritonavir	Lopinavir 200 mg/1; Ritonavir 50 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-164	33342-0164-09
Lopinavir and Ritonavir	Lopinavir 100 mg/1; Ritonavir 25 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-933	42385-0933-60
Lopinavir and ritonavir	Lopinavir 200 mg/1; Ritonavir 50 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-556	31722-0556-1231722-0556-3131722-0556-32+1 more
Lopinavir and ritonavir	Lopinavir 100 mg/1; Ritonavir 25 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-603	31722-0603-1231722-0603-60

Other NDCs under ANDA 213857

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

FDA NDC Directory listings under ANDA 213857
Product	Strength	Form · route	Labeler	Product NDC
Lopinavir and Ritonavir	Lopinavir 100 mg/1; Ritonavir 25 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-933