What is NDC 0093-5528?

0093-5528 is the product NDC for Atazanavir Sulfate, Atazanavir sulfate 300 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Atazanavir Sulfate?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atazanavir Sulfate NDC 0093-5528 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-5528Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-5528Add 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 NDC	11-digit (billing)	Package	Copy
0093-5528-56	0009355285600093552856	30 CAPSULE in 1 BOTTLE (0093-5528-56)Marketed from Dec 27, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Sulfate
Generic name (nonproprietary): atazanavir sulfate
Active ingredients: Atazanavir sulfate — 300 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091673
Marketing start: Dec 27, 2017
Listing expires: Dec 31, 2026
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 0093-5528_61209ea1-63c7-43fc-ac32-d840a8a0906aSPL ID 61209ea1-63c7-43fc-ac32-d840a8a0906aSPL set ID 654b7e08-33d8-47e7-b37f-3681e79c7b8bRxCUI 402246, 402247, 664741UNII 4MT4VIE29P
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

N400093552856 followed by a unit qualifier and the quantity

Package 00093-5528-56. 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 Dec 30, 2024.

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 capsules 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 capsules 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-5528

What is NDC 0093-5528?: 0093-5528 is the product NDC for Atazanavir Sulfate, Atazanavir sulfate 300 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Atazanavir Sulfate.
What is the active ingredient?: Atazanavir sulfate.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Atazanavir Sulfate?: 3 other product NDCs are listed under this name. See all Atazanavir Sulfate 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 Atazanavir Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Atazanavir Sulfateatazanavir	Atazanavir sulfate 150 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-711	65862-0711-0365862-0711-0565862-0711-18+1 more
Atazanavir Sulfate	Atazanavir sulfate 150 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5526	00093-5526-06
Atazanavir Sulfate	Atazanavir sulfate 200 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5527	00093-5527-06

Other NDCs under ANDA 091673

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

FDA NDC Directory listings under ANDA 091673
Product	Strength	Form · route	Labeler	Product NDC
Atazanavir Sulfate	Atazanavir sulfate 150 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5526
Atazanavir Sulfate	Atazanavir sulfate 200 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-5527