What is NDC 0054-3545?

0054-3545 is the product NDC for Meperidine Hydrochloride, Meperidine hydrochloride 50 mg/5mL solution, 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 Meperidine Hydrochloride?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Meperidine Hydrochloride NDC 0054-3545

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-3545Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-3545Add 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
0054-3545-63	0005435456300054354563	500 mL in 1 BOTTLE (0054-3545-63)Marketed from Jan 30, 1985

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): Meperidine Hydrochloride
Generic name (nonproprietary): meperidine hydrochloride
Active ingredients: Meperidine hydrochloride — 50 mg/5mL
Dosage form: Solution
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 088744
Marketing start: Jan 30, 1985
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-3545_677fb454-d83d-4c3c-b095-a58a1c4781b9SPL ID 677fb454-d83d-4c3c-b095-a58a1c4781b9SPL set ID 15bc51a8-1e24-4d33-9a2f-05a41c29acf0RxCUI 861455, 861467, 861479UNII N8E7F7Q170UPC 0300543545632
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

N400054354563 followed by a unit qualifier and the quantity

Package 00054-3545-63. 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 Feb 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Meperidine Hydrochloride Tablets and Oral Solution are indicated for the management of acute 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, reserve opioid analgesics, including Meperidine Hydrochloride Tablets or Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended per…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-3545

What is NDC 0054-3545?: 0054-3545 is the product NDC for Meperidine Hydrochloride, Meperidine hydrochloride 50 mg/5mL solution, 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?: Meperidine Hydrochloride.
What is the active ingredient?: Meperidine hydrochloride.
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 Meperidine Hydrochloride?: 6 other product NDCs are listed under this name. See all Meperidine Hydrochloride 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 Meperidine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Meperidine Hydrochloride	Meperidine hydrochloride 50 mg/1	TabletOral	Genus Lifesciences Inc.	64950-214	64950-0214-0164950-0214-03
Meperidine Hydrochloride	Meperidine hydrochloride 50 mg/1	TabletOral	EPIC PHARMA, LLC	42806-050	42806-0050-0142806-0050-30
Meperidine Hydrochloride	Meperidine hydrochloride 100 mg/1	TabletOral	EPIC PHARMA, LLC	42806-051	42806-0051-01
Meperidine Hydrochloride	Meperidine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6052	00641-6052-25
Meperidine Hydrochloride	Meperidine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6053	00641-6053-25
Meperidine Hydrochloride	Meperidine hydrochloride 100 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6054	00641-6054-25