NDC codes

FDA NDC Directory
Product NDC (as listed)43063-900Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0900Add 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
43063-900-06430630900066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-900-06)Marketed from Oct 11, 2018

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
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079124
Marketing start
Listing expires
Other FDA classes
Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 43063-900_415d1735-9f33-0e91-e063-6394a90a16deSPL ID 415d1735-9f33-0e91-e063-6394a90a16deSPL set ID ff62c5fc-965d-4534-a571-a4f290cb9d83RxCUI 200082UNII 2T8Q726O95, 4B9XT59T7SUPC 0343063900062
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

N443063090006 followed by a unit qualifier and the quantity

Package 43063-0900-06. 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 and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inibitors, 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 43063-900

What is NDC 43063-900?
43063-900 is the product NDC for LAMIVUDINE and ZIDOVUDINE, Lamivudine 150 mg/1; Zidovudine 300 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Lamivudine And ZidovudineLamivudine 150 mg/1; Zidovudine 300 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals, Inc72865-14472865-0144-60
Lamivudine and ZidovudineLamivudine 150 mg/1; Zidovudine 300 mg/1TabletOralMacleods Pharmaceuticals Limited33342-00333342-0003-09
Lamivudine and ZidovudineLamivudine 150 mg/1; Zidovudine 300 mg/1TabletOralBryant Ranch Prepack71335-191671335-1916-0171335-1916-0271335-1916-03
LAMIVUDINE and ZIDOVUDINELamivudine 150 mg/1; Zidovudine 300 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-50631722-0506-0531722-0506-60
LAMIVUDINE and ZIDOVUDINELamivudine 150 mg/1; Zidovudine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-063971335-0639-0171335-0639-0271335-0639-03
Lamivudine and ZidovudineLamivudine 150 mg/1; Zidovudine 300 mg/1Tablet, Film coatedOralExelan Pharmaceuticals Inc.76282-11576282-0115-0576282-0115-60
Lamivudine and ZidovudineLamivudine 150 mg/1; Zidovudine 300 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-73931722-0739-0531722-0739-3131722-0739-60

Other NDCs under ANDA 079124

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

FDA NDC Directory listings under ANDA 079124
ProductStrengthForm · routeLabelerProduct NDC
LAMIVUDINE and ZIDOVUDINELamivudine 150 mg/1; Zidovudine 300 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-506
LAMIVUDINE and ZIDOVUDINELamivudine 150 mg/1; Zidovudine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0639

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