NDC codes

FDA NDC Directory
Product NDC (as listed)51079-204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51079-0204Add 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 NDC11-digit (billing)PackageCopy
51079-204-065107902040650 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)Marketed from Aug 1, 2012

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)
Abacavir Sulfate
Generic name (nonproprietary)
abacavir sulfate
Active ingredients
Abacavir sulfate — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091294
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 51079-204_3a22f5ef-d757-6414-e063-6294a90af7deSPL ID 3a22f5ef-d757-6414-e063-6294a90af7deSPL set ID 80c1702a-973c-436a-90f8-69b29674dca0RxCUI 242679UNII J220T4J9Q2
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

N451079020406 followed by a unit qualifier and the quantity

Package 51079-0204-06. 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 . 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)

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
ProductStrengthForm · routeLabelerProduct NDC
Abacavir SulfateAbacavir sulfate 300 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-4105
Abacavir SulfateAbacavir sulfate 300 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-001

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