What is NDC 0378-4160?

0378-4160 is the product NDC for Atovaquone and Proguanil Hydrochloride, Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Atovaquone, Proguanil hydrochloride.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atovaquone and Proguanil Hydrochloride NDC 0378-4160

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4160Add 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
0378-4160-01	0037841600100378416001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01)Marketed from May 28, 2014

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): Atovaquone and Proguanil Hydrochloride
Generic name (nonproprietary): atovaquone and proguanil hydrochloride
Active ingredients: Atovaquone — 62.5 mg/1Proguanil hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202362
Marketing start: May 28, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Dihydrofolate Reductase Inhibitors (Mechanism)
Identifiers: Product ID 0378-4160_bf8ac578-e07c-44b0-bc85-47919e3a848cSPL ID bf8ac578-e07c-44b0-bc85-47919e3a848c
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

N400378416001 followed by a unit qualifier and the quantity

Package 00378-4160-01. 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 0378-4160

What is NDC 0378-4160?: 0378-4160 is the product NDC for Atovaquone and Proguanil Hydrochloride, Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

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

Other Atovaquone and Proguanil Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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	A-S Medication Solutions	50090-1302	50090-1302-0050090-1302-0150090-1302-02+6 more
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 202362

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

FDA NDC Directory listings under ANDA 202362
Product	Strength	Form · route	Labeler	Product NDC
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4162
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-869