What is NDC 42794-003?

42794-003 is the product NDC for Adefovir Dipivoxil, Adefovir dipivoxil 10 mg/1 tablet, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Sigmapharm Laboratories, LLC, NDC labeler code 42794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Adefovir Dipivoxil?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Adefovir Dipivoxil NDC 42794-003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0003Add 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
42794-003-08	42794000308	1 BOTTLE in 1 CARTON (42794-003-08) / 30 TABLET in 1 BOTTLEMarketed from Jul 18, 2016

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): Adefovir Dipivoxil
Generic name (nonproprietary): adefovir dipivoxil
Active ingredients: Adefovir dipivoxil — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sigmapharm Laboratories, LLCNDC labeler code 42794
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202051
Marketing start: Sep 3, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 42794-003_f7ac2b46-04c8-a739-e053-6394a90a7711SPL ID f7ac2b46-04c8-a739-e053-6394a90a7711SPL set ID e047f3b2-feae-4c5e-9d07-1fefb4c0ec25RxCUI 881341UNII U6Q8Z01514UPC 0342794003080
Pharmacologic class: Hepatitis B 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

N442794000308 followed by a unit qualifier and the quantity

Package 42794-0003-08. 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 Mar 24, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Adefovir Dipivoxil Tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function. For patients 12 to less than 18 years of age, the indication is based on virological and biochemical resp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42794-003

What is NDC 42794-003?: 42794-003 is the product NDC for Adefovir Dipivoxil, Adefovir dipivoxil 10 mg/1 tablet, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Adefovir Dipivoxil.
What is the active ingredient?: Adefovir dipivoxil.
Who is the labeler?: Sigmapharm Laboratories, LLC, NDC labeler code 42794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Adefovir Dipivoxil?: 1 other product NDC are listed under this name. See all Adefovir Dipivoxil 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 Adefovir Dipivoxil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Adefovir dipivoxil	Adefovir dipivoxil 10 mg/1	TabletOral	Apotex Corp.	60505-3947	60505-3947-03