NDC codes

FDA NDC Directory
Product NDC (as listed)31722-509Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0509Add 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 NDC11-digit (billing)PackageCopy
31722-509-603172205096012 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

N431722050960 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zidovudine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ZidovudineZidovudine 300 mg/1TabletOralCoupler LLC67046-161367046-1613-03
ZidovudineZidovudine 10 mg/mLSyrupOralAurobindo Pharma Limited65862-04865862-0048-24

Other NDCs under ANDA 090092

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090092
ProductStrengthForm · routeLabelerProduct NDC
ZidovudineZidovudine 300 mg/1TabletOralCoupler LLC67046-1613

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in