What is NDC 65862-048?

65862-048 is the product NDC for Zidovudine, Zidovudine 10 mg/mL syrup, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zidovudine?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zidovudine NDC 65862-048 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-048Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0048Add 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
65862-048-24	65862004824	240 mL in 1 BOTTLE (65862-048-24)Marketed from Sep 19, 2005

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): Zidovudine
Generic name (nonproprietary): zidovudine
Active ingredients: Zidovudine — 10 mg/mL
Dosage form: Syrup
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077268
Marketing start: Sep 19, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 65862-048_19584bb3-e849-4839-961f-c38bb07a4e8cSPL ID 19584bb3-e849-4839-961f-c38bb07a4e8cSPL set ID 51abd2ce-6be1-412d-b806-5f24935ac5e3RxCUI 756209UNII 4B9XT59T7SUPC 0365862048240
Pharmacologic class: 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

N465862004824 followed by a unit qualifier and the quantity

Package 65862-0048-24. 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 Feb 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Zidovudine oral solution is a nucleoside analogue reverse transcriptase inhibitor indicated for: Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1) Prevention of maternal-fetal HIV-1 transmission. (1.2) 1.1 Treatment of HIV-1 Zidovudine oral solution, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine oral solution is indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration (2.3) ]. The indication is based on a dosing regimen that incl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-048

What is NDC 65862-048?: 65862-048 is the product NDC for Zidovudine, Zidovudine 10 mg/mL syrup, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zidovudine.
What is the active ingredient?: Zidovudine.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zidovudine?: 2 other product NDCs are listed under this name. See all 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 Zidovudine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zidovudine	Zidovudine 300 mg/1	TabletOral	Coupler LLC	67046-1613	67046-1613-03
Zidovudine	Zidovudine 300 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-509	31722-0509-60