What is NDC 43386-480?

43386-480 is the product NDC for Orphenadrine Citrate, Orphenadrine citrate 100 mg/1 tablet, extended release, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals, Inc., NDC labeler code 43386. 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 43386-480

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-480Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0480Add 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
43386-480-24	4338604802443386048024	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24)Marketed from Jun 19, 1998
43386-480-26	4338604802643386048026	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26)Marketed from Jun 19, 1998
43386-480-28	4338604802843386048028	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-28)Marketed from Jun 19, 1998

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): Orphenadrine Citrate
Generic name (nonproprietary): orphenadrine citrate
Active ingredients: Orphenadrine citrate — 100 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040284
Marketing start: Jun 19, 1998
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 43386-480_e80ecc89-bd45-4796-850b-c379a79ac7abSPL ID e80ecc89-bd45-4796-850b-c379a79ac7abSPL set ID 7b76c8a7-dd0c-481c-8299-26dfd38ce066RxCUI 994521UNII 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 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

N443386048024 followed by a unit qualifier and the quantity

Package 43386-0480-24. 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 Sep 10, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Orphenadrine citrate extended-release tablets are 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 43386-480

What is NDC 43386-480?: 43386-480 is the product NDC for Orphenadrine Citrate, Orphenadrine citrate 100 mg/1 tablet, extended release, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 3 package NDCs, 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?: Lupin Pharmaceuticals, Inc., NDC labeler code 43386. 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 60 mg/2mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6182	00641-6182-25
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

All 19 Orphenadrine Citrate NDCs

Other NDCs under ANDA 040284

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

FDA NDC Directory listings under ANDA 040284
Product	Strength	Form · route	Labeler	Product NDC
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	43063-407
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Lake Erie Medical DBA Quality Care Products LLC	49999-046
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-0169
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	St. Mary's Medical Park Pharmacy	60760-810
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-122
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-1564
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	NuCare Pharmaceuticals, Inc.	66267-158
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-9138
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4506
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2020
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0340
Orphenadrine Citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	82868-040
Orphenadrine Citrate ERorphenadrine citrate	Orphenadrine citrate 100 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0117