Prescription drug · ANDA
Entecavir NDC 70771-1019
Entecavir .5 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1019-1 | 7077110190170771101901 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1019-1)Marketed from Aug 10, 2017 | |
| 70771-1019-3 | 7077110190370771101903 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1019-3)Marketed from Aug 10, 2017 | |
| 70771-1019-4 | 7077110190470771101904 | 10 BLISTER PACK in 1 CARTON (70771-1019-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1019-2)Marketed from Aug 10, 2017 | |
| 70771-1019-9 | 7077110190970771101909 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1019-9)Marketed from Aug 10, 2017 |
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)
- Entecavir
- Generic name (nonproprietary)
- entecavir
- Active ingredients
- Entecavir — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206745
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1019_eb274d01-4108-4d2e-8e2b-8656b90684c0SPL ID eb274d01-4108-4d2e-8e2b-8656b90684c0SPL set ID 0e3b2a0a-9076-4907-bbaf-eb6a65bb9481RxCUI 485434, 485436UNII 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
N470771101901followed by a unit qualifier and the quantityPackage 70771-1019-01. 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 .
About NDC 70771-1019
- What is NDC 70771-1019?
- 70771-1019 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Entecavir.
- What is the active ingredient?
- Entecavir.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Entecavir?
- 27 other product NDCs are listed under this name. See all Entecavir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Entecavir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Entecavirentecavir anhydrous | Entecavir anhydrous .5 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-457 | 42494-0457-30 |
| Entecavirentecavir anhydrous | Entecavir anhydrous 1 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-458 | 42494-0458-30 |
| Entecavir | Entecavir .5 mg/1 | Tablet, Film coatedOral | Yaopharma Co., Ltd. | 50771-013 | 50771-0013-0150771-0013-02 |
| Entecavir | Entecavir 1 mg/1 | Tablet, Film coatedOral | Yaopharma Co., Ltd. | 50771-014 | 50771-0014-01 |
| Entecavir | Entecavir anhydrous .5 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-667 | 42806-0667-30 |
| Entecavir | Entecavir anhydrous 1 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-668 | 42806-0668-30 |
| Entecavir | Entecavir .5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-589 | 51407-0589-30 |
| Entecavir | Entecavir .5 mg/1 | TabletOral | Carlsbad Technology, Inc. | 61442-311 | 61442-0311-30 |
| Entecavir | Entecavir .5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-261 | 42291-0261-30 |
| Entecavir | Entecavir .5 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-658 | 42806-0658-30 |
Other NDCs under ANDA 206745
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 |
|---|---|---|---|---|
| Entecavir | Entecavir .5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-920 |
| Entecavir | Entecavir 1 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-921 |
| Entecavir | Entecavir 1 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1020 |