Prescription drug · ANDA
Atovaquone Oral Suspension (Atovaquone) NDC 10702-223
Atovaquone 750 mg/5mL · Suspension · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-223-21 | 1070202232110702022321 | 1 BOTTLE, PLASTIC in 1 CARTON (10702-223-21) / 210 mL in 1 BOTTLE, PLASTICMarketed from Mar 29, 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)
- Atovaquone Oral Suspension
- Generic name (nonproprietary)
- atovaquone
- Active ingredients
- Atovaquone — 750 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- KVK-Tech, Inc.NDC labeler code 10702
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210510
- Marketing start
- Listing expires
- Identifiers
- Product ID 10702-223_5462a6ca-39eb-3b07-e063-6394a90a9020SPL ID 5462a6ca-39eb-3b07-e063-6394a90a9020SPL set ID b31ff20a-c363-4be0-9bc0-3081c163b63cRxCUI 308429UNII Y883P1Z2LTUPC 0310702223219
- Pharmacologic class
- Antimalarial; Antiprotozoal
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
N410702022321followed by a unit qualifier and the quantityPackage 10702-0223-21. 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 .
Indications (excerpt from the label)
Atovaquone oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1) Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2) Limitations of Use (1.3): Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2] >45 mm Hg) with atovaquone oral suspension has not been studied. The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pneum…
Excerpt only. Read the full label for complete information.
About NDC 10702-223
- What is NDC 10702-223?
- 10702-223 is the product NDC for Atovaquone Oral Suspension (atovaquone), Atovaquone 750 mg/5mL suspension, listed with the FDA by KVK-Tech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atovaquone Oral Suspension (Atovaquone).
- What is the active ingredient?
- Atovaquone.
- Who is the labeler?
- KVK-Tech, Inc., NDC labeler code 10702. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atovaquone Oral Suspension?
- 1 other product NDC are listed under this name. See all Atovaquone Oral Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atovaquone Oral Suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atovaquone Oral Suspensionatovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Kesin Pharma Corporation | 81033-105 | 81033-0105-2281033-0105-42 |
Other NDCs under ANDA 210510
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 |
|---|---|---|---|---|
| Atovaquone Oral Suspensionatovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Kesin Pharma Corporation | 81033-105 |