What is NDC 0378-4105?

0378-4105 is the product NDC for Abacavir Sulfate, Abacavir sulfate 300 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.

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 Abacavir Sulfate?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Abacavir Sulfate NDC 0378-4105 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4105Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4105Add 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
0378-4105-91	0037841059100378410591	1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jun 19, 2012

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): Abacavir Sulfate
Generic name (nonproprietary): abacavir sulfate
Active ingredients: Abacavir sulfate — 300 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 091294
Marketing start: Jun 19, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 0378-4105_3ae56d4c-73b4-497f-bc93-554a247f2359SPL ID 3ae56d4c-73b4-497f-bc93-554a247f2359SPL set ID 5676d391-f9a4-44be-9604-954b3d8d0e2bRxCUI 242679UNII J220T4J9Q2UPC 0303784105917
Pharmacologic class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase 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

N400378410591 followed by a unit qualifier and the quantity

Package 00378-4105-91. 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 Jan 8, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-4105

What is NDC 0378-4105?: 0378-4105 is the product NDC for Abacavir Sulfate, Abacavir sulfate 300 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?: Abacavir Sulfate.
What is the active ingredient?: Abacavir sulfate.
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 Abacavir Sulfate?: 2 other product NDCs are listed under this name. See all Abacavir 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 Abacavir Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Abacavir Sulfate	Abacavir sulfate 300 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-001	48433-0001-06
Abacavir Sulfate	Abacavir sulfate 300 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-204	51079-0204-06

Other NDCs under ANDA 091294

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

FDA NDC Directory listings under ANDA 091294
Product	Strength	Form · route	Labeler	Product NDC
Abacavir Sulfate	Abacavir sulfate 300 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-001
Abacavir Sulfate	Abacavir sulfate 300 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-204