What is NDC 0641-6182?

0641-6182 is the product NDC for Orphenadrine citrate, Orphenadrine citrate 60 mg/2mL 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 Orphenadrine citrate?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Orphenadrine citrate NDC 0641-6182

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6182Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6182Add 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
0641-6182-25	0064161822500641618225	25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01)Marketed from Apr 28, 2003

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): Orphenadrine citrate
Generic name (nonproprietary): orphenadrine citrate
Active ingredients: Orphenadrine citrate — 60 mg/2mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040463
Marketing start: Apr 28, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 0641-6182_dde13b7f-78fb-4b9a-bc16-a41bf45042beSPL ID dde13b7f-78fb-4b9a-bc16-a41bf45042beSPL set ID ed406e8a-ec00-4711-ae2b-3c5af4f15438RxCUI 994541UNII X0A40N8I4S
Pharmacologic class: Muscle Relaxant

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

N400641618225 followed by a unit qualifier and the quantity

Package 00641-6182-25. 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 Aug 8, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0641-6182

What is NDC 0641-6182?: 0641-6182 is the product NDC for Orphenadrine citrate, Orphenadrine citrate 60 mg/2mL 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?: Orphenadrine citrate.
What is the active ingredient?: Orphenadrine citrate.
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 Orphenadrine citrate?: 18 other product NDCs are listed under this name. See all Orphenadrine citrate 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 Orphenadrine citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4506	70518-4506-0070518-4506-0170518-4506-02+1 more
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	82868-040	82868-0040-14
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0340	80425-0340-0180425-0340-02
Orphenadrine Citrate	Orphenadrine citrate 30 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-651	25021-0651-02
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Lake Erie Medical DBA Quality Care Products LLC	49999-046	49999-0046-60
Orphenadrine Citrate	Orphenadrine citrate 30 mg/mL	InjectionIntramuscular, Intravenous	Actavis Pharma, Inc.	0591-3222	00591-3222-47
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	St. Mary's Medical Park Pharmacy	60760-810	60760-0810-30
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Sandoz Inc	0185-0022	00185-0022-01
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-632	63187-0632-3063187-0632-6063187-0632-90
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	RedPharm Drug	67296-1077	67296-1077-01

All 19 Orphenadrine citrate NDCs