Prescription drug · ANDA
Atovaquone and Proguanil Hydrochloride NDC 50090-1302
Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1302-0 | 5009013020050090130200 | 7 TABLET, FILM COATED in 1 BOTTLE (50090-1302-0)Marketed from Nov 28, 2014 | |
| 50090-1302-1 | 5009013020150090130201 | 12 TABLET, FILM COATED in 1 BOTTLE (50090-1302-1)Marketed from Nov 28, 2014 | |
| 50090-1302-2 | 5009013020250090130202 | 14 TABLET, FILM COATED in 1 BOTTLE (50090-1302-2)Marketed from Nov 28, 2014 | |
| 50090-1302-3 | 5009013020350090130203 | 16 TABLET, FILM COATED in 1 BOTTLE (50090-1302-3)Marketed from Nov 28, 2014 | |
| 50090-1302-4 | 5009013020450090130204 | 24 TABLET, FILM COATED in 1 BOTTLE (50090-1302-4)Marketed from Nov 28, 2014 | |
| 50090-1302-5 | 5009013020550090130205 | 5 TABLET, FILM COATED in 1 BOTTLE (50090-1302-5)Marketed from Nov 28, 2014 | |
| 50090-1302-6 | 5009013020650090130206 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-1302-6)Marketed from Nov 28, 2014 | |
| 50090-1302-8 | 5009013020850090130208 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-1302-8)Marketed from Sep 29, 2017 | |
| 50090-1302-9 | 5009013020950090130209 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-1302-9)Marketed from Sep 28, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 and Proguanil Hydrochloride
- Generic name (nonproprietary)
- atovaquone and proguanil hydrochloride
- Active ingredients
- Atovaquone — 250 mg/1Proguanil hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091211
- Marketing start
- Listing expires
- Other FDA classes
- Dihydrofolate Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-1302_0f4d7baa-42e4-4375-ab9b-97f96eebb3feSPL ID 0f4d7baa-42e4-4375-ab9b-97f96eebb3fe
- 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
N450090130200followed by a unit qualifier and the quantityPackage 50090-1302-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50090-1302
- What is NDC 50090-1302?
- 50090-1302 is the product NDC for Atovaquone and Proguanil Hydrochloride, Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 9 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atovaquone and Proguanil Hydrochloride.
- What is the active ingredient?
- Atovaquone, Proguanil hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 and Proguanil Hydrochloride?
- 7 other product NDCs are listed under this name. See all Atovaquone and Proguanil Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atovaquone and Proguanil Hydrochloride 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 and Proguanil Hydrochloride | Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4160 | 00378-4160-01 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4162 | 00378-4162-01 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-869 | 51407-0869-0151407-0869-24 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-245 | 68001-0245-0068001-0245-15 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc.,USA | 68462-404 | 68462-0404-0168462-0404-67 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3160 | 71335-3160-0171335-3160-0271335-3160-03+2 more |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-879 | 63187-0879-1663187-0879-24 |
Other NDCs under ANDA 091211
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 and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-879 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-245 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc.,USA | 68462-404 |
| Atovaquone and Proguanil Hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3160 |
| Atovaquone and Proguanil Hydrochloride Pediatric | Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc.,USA | 68462-402 |