Prescription drug · ANDA
Zidovudine NDC 31722-509
Zidovudine 300 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-509-60 | 31722050960 | 12 BOTTLE in 1 CASE (31722-509-60) / 60 TABLET in 1 BOTTLEMarketed from Apr 25, 2008 |
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)
- Zidovudine
- Generic name (nonproprietary)
- zidovudine
- Active ingredients
- Zidovudine — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090092
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-509_fbbb4305-5ef7-b4b5-e053-6294a90a278cSPL ID fbbb4305-5ef7-b4b5-e053-6294a90a278cSPL set ID ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4RxCUI 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
N431722050960followed by a unit qualifier and the quantityPackage 31722-0509-60. 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)
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.
About NDC 31722-509
- What is NDC 31722-509?
- 31722-509 is the product NDC for Zidovudine, Zidovudine 300 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. 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?
- 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 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.
Related NDCs: other Zidovudine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zidovudine | Zidovudine 300 mg/1 | TabletOral | Coupler LLC | 67046-1613 | 67046-1613-03 |
| 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zidovudine | Zidovudine 300 mg/1 | TabletOral | Coupler LLC | 67046-1613 |