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 NDC11-digit (billing)PackageCopy
43386-480-2443386048024100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24)Marketed from Jun 19, 1998
43386-480-2643386048026500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26)Marketed from Jun 19, 1998
43386-480-28433860480281000 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 citrate100 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040284
Marketing start
Listing expires
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 .

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)

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
ProductStrengthForm · routeLabelerProduct NDC
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4506
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC82868-040
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralLake Erie Medical DBA Quality Care Products LLC49999-046
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-810
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.43063-407
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-1564
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-9138
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-2020
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0340
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-0169
Orphenadrine Citrate ERorphenadrine citrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0117
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralProficient Rx LP63187-122
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.66267-158

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