NDC codes

FDA NDC Directory
Product NDC (as listed)31722-654Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0654Add 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
31722-654-10317220654101000 CAPSULE in 1 BOTTLE (31722-654-10)Marketed from Feb 7, 2022
31722-654-3131722065431100 BLISTER PACK in 1 CARTON (31722-654-31) / 10 CAPSULE in 1 BLISTER PACKMarketed from Feb 7, 2022
31722-654-603172206546060 CAPSULE in 1 BOTTLE (31722-654-60)Marketed from Feb 7, 2022

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)
Atazanavir
Generic name (nonproprietary)
atazanavir
Active ingredients
Atazanavir sulfate — 200 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212278
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)UDP Glucuronosyltransferases Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)
Identifiers
Product ID 31722-654_30891c38-5d64-7df7-e063-6394a90ae762SPL ID 30891c38-5d64-7df7-e063-6394a90ae762SPL set ID 8a0c609f-e296-4925-a35c-e93a04467655RxCUI 402246, 402247, 664741UNII 4MT4VIE29PUPC 0331722654609, 0331722653602, 0331722655309
Pharmacologic class
Protease 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

N431722065410 followed by a unit qualifier and the quantity

Package 31722-0654-10. 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)

Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: • Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4 )] . • Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4 )] . Atazanavir capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212278

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

FDA NDC Directory listings under ANDA 212278
ProductStrengthForm · routeLabelerProduct NDC
AtazanavirAtazanavir sulfate 150 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-653
AtazanavirAtazanavir sulfate 300 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-655

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