NDC codes

FDA NDC Directory
Product NDC (as listed)43063-407Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0407Add 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
43063-407-14430630407144306304071414 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14)Marketed from Jun 18, 2013
43063-407-20430630407204306304072020 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20)Marketed from Jun 18, 2013
43063-407-30430630407304306304073030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-30)Marketed from Jun 18, 2013
43063-407-60430630407604306304076060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-60)Marketed from Jun 18, 2013

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
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
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 43063-407_47d2a4d7-5572-e023-e063-6394a90a3617SPL ID 47d2a4d7-5572-e023-e063-6394a90a3617SPL set ID 87d78229-f022-4b42-a03c-4e6a985c714fRxCUI 994521UNII X0A40N8I4SUPC 0343063407301
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

N443063040714 followed by a unit qualifier and the quantity

Package 43063-0407-14. 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)

About NDC 43063-407

What is NDC 43063-407?
43063-407 is the product NDC for Orphenadrine Citrate, Orphenadrine citrate 100 mg/1 tablet, extended release, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 4 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-450670518-4506-0070518-4506-0170518-4506-02+1 more
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC82868-04082868-0040-14
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-034080425-0340-0180425-0340-02
Orphenadrine CitrateOrphenadrine citrate 30 mg/mLInjection, SolutionIntramuscular, IntravenousSagent Pharmaceuticals25021-65125021-0651-02
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralLake Erie Medical DBA Quality Care Products LLC49999-04649999-0046-60
Orphenadrine CitrateOrphenadrine citrate 30 mg/mLInjectionIntramuscular, IntravenousActavis Pharma, Inc.0591-322200591-3222-47
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-81060760-0810-30
Orphenadrine citrateOrphenadrine citrate 60 mg/2mLInjectionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0641-618200641-6182-25
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralSandoz Inc0185-002200185-0022-01
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralProficient Rx LP63187-63263187-0632-3063187-0632-6063187-0632-90

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
ProductStrengthForm · routeLabelerProduct NDC
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.43386-480
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralLake Erie Medical DBA Quality Care Products LLC49999-046
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-0169
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-810
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralProficient Rx LP63187-122
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-1564
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.66267-158
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-9138
Orphenadrine CitrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4506
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 releaseOralNorthwind Health Company, LLC82868-040
Orphenadrine Citrate ERorphenadrine citrateOrphenadrine citrate 100 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0117

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