Complera NDC 61958-1101

NDC codes

FDA NDC Directory

Product NDC (as listed)61958-1101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61958-1101Add 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
61958-1101-1	61958110101	30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)Marketed from Aug 10, 2011

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): Complera
Generic name (nonproprietary): emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Active ingredients: Emtricitabine — 200 mg/1Rilpivirine hydrochloride — 25 mg/1Tenofovir disoproxil fumarate — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Gilead Sciences, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202123
Marketing start: Aug 10, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
Identifiers: Product ID 61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6SPL ID 21d7850d-11ea-43cc-84a5-0dae02a19ce6SPL set ID d637cfab-f1e8-4eb3-a1b3-f85ca3bec612RxCUI 1147334, 1147337UNII G70B4ETF4S, 212WAX8KDD, OTT9J7900I
Pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor; 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

N461958110101 followed by a unit qualifier and the quantity

Package 61958-1101-01. 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

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