What is NDC 0641-6054?

0641-6054 is the product NDC for Meperidine Hydrochloride, Meperidine hydrochloride 100 mg/mL injection, 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 0641. 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 0641-6054

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6054Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6054Add 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
0641-6054-25	0064160542500641605425	25 VIAL in 1 CARTON (0641-6054-25) / 1 mL in 1 VIAL (0641-6054-01)Marketed from Jan 22, 1975

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 — 100 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080445
Marketing start: Jan 22, 1975
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0641-6054_9566d54d-7343-4695-94ff-8b5f2d384c81SPL ID 9566d54d-7343-4695-94ff-8b5f2d384c81SPL set ID e0e998da-f056-4fce-be8e-ed60cf3b461bRxCUI 861476, 1665685, 1665697UNII N8E7F7Q170
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400641605425 followed by a unit qualifier and the quantity

Package 00641-6054-25. 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 Apr 9, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. Meperidine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, for obstetrical analgesia, and for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0641-6054

What is NDC 0641-6054?: 0641-6054 is the product NDC for Meperidine Hydrochloride, Meperidine hydrochloride 100 mg/mL injection, 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 0641. 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 50 mg/5mL	SolutionOral	Hikma Pharmaceuticals USA Inc.	0054-3545	00054-3545-63
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

Other NDCs under ANDA 080445

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

FDA NDC Directory listings under ANDA 080445
Product	Strength	Form · route	Labeler	Product NDC
Meperidine Hydrochloride	Meperidine hydrochloride 25 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6052
Meperidine Hydrochloride	Meperidine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6053