What is NDC 0054-0438?

0054-0438 is the product NDC for Levorphanol Tartrate, Levorphanol tartrate 2 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 0054-0438

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0438Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0438Add 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
0054-0438-25	0005404382500054043825	100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)Marketed from Feb 2, 2023

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): Levorphanol Tartrate
Generic name (nonproprietary): levorphanol tartrate
Active ingredients: Levorphanol tartrate — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074278
Marketing start: Mar 31, 2000
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0438_0bfc1a93-9279-415f-8510-9eaa522c0a5fSPL ID 0bfc1a93-9279-415f-8510-9eaa522c0a5fSPL set ID b2ab70e4-ca0c-4a73-9c98-974bf94e890cRxCUI 197873UNII 04WQU6T9QI
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

N400054043825 followed by a unit qualifier and the quantity

Package 00054-0438-25. 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 Nov 17, 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ], reserve opioid analgesics, including levorphanol tartrate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0438

What is NDC 0054-0438?: 0054-0438 is the product NDC for Levorphanol Tartrate, Levorphanol tartrate 2 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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	Virtus Pharmaceuticals, LLC	69543-417	69543-0417-10
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