What is NDC 69543-417?

69543-417 is the product NDC for Levorphanol Tartrate, Levorphanol tartrate 2 mg/1 tablet, listed with the FDA by Virtus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Virtus Pharmaceuticals, LLC, NDC labeler code 69543. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Levorphanol Tartrate?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levorphanol Tartrate NDC 69543-417

NDC codes

FDA NDC Directory

Product NDC (as listed)69543-417Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69543-0417Add 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
69543-417-10	6954304171069543041710	100 TABLET in 1 BOTTLE (69543-417-10)Marketed from Sep 1, 2020

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): Levorphanol Tartrate
Generic name (nonproprietary): levorphanol tartrate
Active ingredients: Levorphanol tartrate — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Virtus Pharmaceuticals, LLCNDC labeler code 69543
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211484
Marketing start: Sep 1, 2020
Marketing end: Jul 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 69543-417_42f6d390-228a-4790-8372-2e822b5d7e9dSPL ID 42f6d390-228a-4790-8372-2e822b5d7e9dSPL set ID 6e7ca993-c8b9-4510-a2b0-5bcc678d2571RxCUI 197873UNII 04WQU6T9QIUPC 0369543417103
Pharmacologic class: Opioid Agonist

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

N469543041710 followed by a unit qualifier and the quantity

Package 69543-0417-10. 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 Jul 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve Levorphanol Tartrate Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): • Have not been tolerated or are not expected to be tolerated, • Have not provided adequate analgesia or are not expected to provide adequate analgesia Levorphanol Tartrate Tablets should not be used for an extended period of time unless …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69543-417

What is NDC 69543-417?: 69543-417 is the product NDC for Levorphanol Tartrate, Levorphanol tartrate 2 mg/1 tablet, listed with the FDA by Virtus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Levorphanol Tartrate.
What is the active ingredient?: Levorphanol tartrate.
Who is the labeler?: Virtus Pharmaceuticals, LLC, NDC labeler code 69543. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levorphanol Tartrate?: 9 other product NDCs are listed under this name. See all Levorphanol Tartrate 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 Levorphanol Tartrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	ACERTIS PHARMACEUTICALS, LLC	72989-417	72989-0417-10
Levorphanol Tartrate	Levorphanol tartrate 3 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-058	57664-0058-88
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-762	57664-0762-88
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	Bryant Ranch Prepack	72162-2309	72162-2309-01
Levorphanol Tartrate	Levorphanol tartrate 3 mg/1	TabletOral	Lannett Company, Inc.	0527-3237	00527-3237-37
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	SpecGx LLC	0406-2224	00406-2224-01
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	Lannett Company, Inc.	0527-3236	00527-3236-37
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-2093	63629-2093-01
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0438	00054-0438-25

Other NDCs under ANDA 211484

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

FDA NDC Directory listings under ANDA 211484
Product	Strength	Form · route	Labeler	Product NDC
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	Bryant Ranch Prepack	72162-2309
Levorphanol Tartrate	Levorphanol tartrate 2 mg/1	TabletOral	ACERTIS PHARMACEUTICALS, LLC	72989-417