Prescription drug · ANDA
LAMIVUDINE and ZIDOVUDINE NDC 43063-900
Lamivudine 150 mg/1; Zidovudine 300 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-900-06 | 43063090006 | 6 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
N443063090006followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other LAMIVUDINE and ZIDOVUDINE products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamivudine And Zidovudine | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals, Inc | 72865-144 | 72865-0144-60 |
| Lamivudine and Zidovudine | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-003 | 33342-0003-09 |
| Lamivudine and Zidovudine | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1916 | 71335-1916-0171335-1916-0271335-1916-03 |
| LAMIVUDINE and ZIDOVUDINE | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-506 | 31722-0506-0531722-0506-60 |
| LAMIVUDINE and ZIDOVUDINE | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0639 | 71335-0639-0171335-0639-0271335-0639-03 |
| Lamivudine and Zidovudine | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-115 | 76282-0115-0576282-0115-60 |
| Lamivudine and Zidovudine | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-739 | 31722-0739-0531722-0739-3131722-0739-60 |
Other NDCs under ANDA 079124
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| LAMIVUDINE and ZIDOVUDINE | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-506 |
| LAMIVUDINE and ZIDOVUDINE | Lamivudine 150 mg/1; Zidovudine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0639 |