Prescription drug · ANDA
lamivudine NDC 31722-001
Lamivudine 100 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-001-02 | 31722000102 | 20 BLISTER PACK in 1 CARTON (31722-001-02) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 21, 2019 | |
| 31722-001-60 | 31722000160 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-001-60)Marketed from Mar 21, 2019 |
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)
- lamivudine
- Generic name (nonproprietary)
- lamivudine
- Active ingredients
- Lamivudine — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211306
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-001_2b449c4a-56db-0d5f-e063-6394a90ad576SPL ID 2b449c4a-56db-0d5f-e063-6394a90ad576SPL set ID e90671c6-7fff-48f4-8898-29f02d049c8bRxCUI 205328UNII 2T8Q726O95UPC 0331722001601
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; 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
N431722000102followed by a unit qualifier and the quantityPackage 31722-0001-02. 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)
Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies ( 14.1 , 14.2 )]. The following points should be considered when initiating therapy with lamivudine tablets (HBV): • Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. • Lamivudine tablets (HBV) have not been evaluated in patients co-infected with HIV, hepatitis C virus…
Excerpt only. Read the full label for complete information.
About NDC 31722-001
- What is NDC 31722-001?
- 31722-001 is the product NDC for lamivudine, Lamivudine 100 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lamivudine.
- What is the active ingredient?
- Lamivudine.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for lamivudine?
- 24 other product NDCs are listed under this name. See all lamivudine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other lamivudine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1459 | 67046-1459-03 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-720 | 60687-0720-21 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-001 | 33342-0001-09 |
| Lamivudine | Lamivudine 300 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-002 | 33342-0002-07 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-710 | 64380-0710-03 |
| Lamivudine | Lamivudine 300 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-711 | 64380-0711-04 |
| Lamivudine | Lamivudine 150 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-623 | 50742-0623-60 |
| Lamivudine | Lamivudine 300 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-624 | 50742-0624-60 |
| Lamivudine | Lamivudine 10 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-274 | 57237-0274-24 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-025 | 65862-0025-1065862-0025-60 |