What is NDC 61919-493?

61919-493 is the product NDC for Fluconazole, Fluconazole 200 mg/1 tablet, listed with the FDA by Direct Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct Rx, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluconazole?

162 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluconazole NDC 61919-493 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61919-493Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61919-0493Add 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
61919-493-03	6191904930361919049303	3 TABLET in 1 BOTTLE (61919-493-03)Marketed from Apr 8, 2019

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): Fluconazole
Generic name (nonproprietary): fluconazole
Active ingredients: Fluconazole — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct RxNDC labeler code 61919
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208963
Marketing start: Apr 8, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 61919-493_0e88c9e2-8dbd-917c-e063-6294a90a6ec9SPL ID 0e88c9e2-8dbd-917c-e063-6294a90a6ec9SPL set ID 69f199fa-bb92-4837-8b12-427a1c71f622RxCUI 197700UNII 8VZV102JFY
Pharmacologic class: Azole Antifungal

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

N461919049303 followed by a unit qualifier and the quantity

Package 61919-0493-03. 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 9, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 61919-493

What is NDC 61919-493?: 61919-493 is the product NDC for Fluconazole, Fluconazole 200 mg/1 tablet, listed with the FDA by Direct Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluconazole.
What is the active ingredient?: Fluconazole.
Who is the labeler?: Direct Rx, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluconazole?: 162 other product NDCs are listed under this name. See all Fluconazole 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 Fluconazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluconazole	Fluconazole 200 mg/1	TabletOral	Coupler LLC	67046-2044	67046-2044-03
Fluconazole	Fluconazole 100 mg/1	TabletOral	Coupler LLC	67046-0623	67046-0623-03
Fluconazole	Fluconazole 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4723	70518-4723-00
fluconazole	Fluconazole 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4163	68788-4163-0068788-4163-0168788-4163-02+4 more
Fluconazole	Fluconazole 100 mg/1	TabletOral	Coupler LLC	67046-2000	67046-2000-03
Fluconazole	Fluconazole 50 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-396	77771-0396-30
Fluconazole	Fluconazole 100 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-397	77771-0397-0177771-0397-30
Fluconazole	Fluconazole 150 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-398	77771-0398-1177771-0398-13
Fluconazole	Fluconazole 200 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-399	77771-0399-0177771-0399-30
Fluconazole	Fluconazole 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-4413	70518-4413-00

All 163 Fluconazole NDCs

Other NDCs under ANDA 208963

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

FDA NDC Directory listings under ANDA 208963
Product	Strength	Form · route	Labeler	Product NDC
fluconazole	Fluconazole 150 mg/1	TabletOral	direct rx	72189-149
fluconazole	Fluconazole 100 mg/1	TabletOral	A-S Medication Solutions	50090-5299
fluconazole	Fluconazole 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-0686
fluconazole	Fluconazole 150 mg/1	TabletOral	A-S Medication Solutions	50090-4425
fluconazole	Fluconazole 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4163
fluconazole	Fluconazole 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-0769
fluconazole	Fluconazole 200 mg/1	TabletOral	Proficient Rx LP	71205-283
fluconazole	Fluconazole 100 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4501
fluconazole	Fluconazole 50 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1063
fluconazole	Fluconazole 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1064
fluconazole	Fluconazole 150 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1065
fluconazole	Fluconazole 200 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1066
fluconazole	Fluconazole 50 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	70710-1137
fluconazole	Fluconazole 200 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	70710-1140
fluconazole	Fluconazole 100 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	70710-1138
fluconazole	Fluconazole 150 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	70710-1139
fluconazole	Fluconazole 200 mg/1	TabletOral	A-S Medication Solutions	50090-4864
fluconazole	Fluconazole 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-2415
fluconazole	Fluconazole 150 mg/1	TabletOral	Proficient Rx LP	71205-081
Fluconazole	Fluconazole 100 mg/1	TabletOral	direct rx	72189-140