What is NDC 67046-1613?

67046-1613 is the product NDC for Zidovudine, Zidovudine 300 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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 67046-1613 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1613Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1613Add 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
67046-1613-3	67046161303	30 TABLET in 1 BLISTER PACK (67046-1613-3)Marketed from Nov 13, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090092
Marketing start: Nov 13, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 67046-1613_48c0ccac-2fe3-0fe2-e063-6294a90a2a9cSPL ID 48c0ccac-2fe3-0fe2-e063-6294a90a2a9cSPL set ID 437f55b2-f6d9-0065-e063-6294a90ab929RxCUI 199663UNII 4B9XT59T7S
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

N467046161303 followed by a unit qualifier and the quantity

Package 67046-1613-03. 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 Jan 19, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Zidovudine tablets are 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 tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine tablets are 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 included 3 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1613

What is NDC 67046-1613?: 67046-1613 is the product NDC for Zidovudine, Zidovudine 300 mg/1 tablet, listed with the FDA by Coupler LLC. 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?: Coupler LLC, NDC labeler code 67046. 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	Camber Pharmaceuticals, Inc.	31722-509	31722-0509-60
Zidovudine	Zidovudine 10 mg/mL	SyrupOral	Aurobindo Pharma Limited	65862-048	65862-0048-24

Other NDCs under ANDA 090092

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

FDA NDC Directory listings under ANDA 090092
Product	Strength	Form · route	Labeler	Product NDC
Zidovudine	Zidovudine 300 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-509