Prescription drug · NDA
Baraclude (Entecavir) NDC 0003-1612
Entecavir 1 mg/1 · Tablet, Film coated · Oral · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-1612-12 | 0000316121200003161212 | 1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 29, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Baraclude
- Generic name (nonproprietary)
- entecavir
- Active ingredients
- Entecavir — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021797
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 0003-1612_275a2584-65d6-40f8-8aac-49eb54479f6dSPL ID 275a2584-65d6-40f8-8aac-49eb54479f6dSPL set ID 046e61c9-9298-4b2e-b76e-b26b81fecd20RxCUI 485434, 485436, 485536, 578457, 578459, 607579UNII 5968Y6H45M
- 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
N400003161212followed by a unit qualifier and the quantityPackage 00003-1612-12. 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)
BARACLUDE ® (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 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. BARACLUDE is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
Excerpt only. Read the full label for complete information.
About NDC 0003-1612
- What is NDC 0003-1612?
- 0003-1612 is the product NDC for Baraclude (entecavir), Entecavir 1 mg/1 tablet, film coated, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Baraclude (Entecavir).
- What is the active ingredient?
- Entecavir.
- Who is the labeler?
- E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Baraclude?
- 2 other product NDCs are listed under this name. See all Baraclude NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Baraclude products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Baracludeentecavir | Entecavir .5 mg/1 | Tablet, Film coatedOral | E.R. Squibb & Sons, L.L.C. | 0003-1611 | 00003-1611-12 |
| Baracludeentecavir | Entecavir .05 mg/mL | SolutionOral | E.R. Squibb & Sons, L.L.C. | 0003-1614 | 00003-1614-12 |
Other NDCs under NDA 021797
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 |
|---|---|---|---|---|
| Baracludeentecavir | Entecavir .5 mg/1 | Tablet, Film coatedOral | E.R. Squibb & Sons, L.L.C. | 0003-1611 |