NDC codes

FDA NDC Directory
Product NDC (as listed)68462-461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0461Add 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
68462-461-056846204610568462046105500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05)Marketed from Aug 13, 2010
68462-461-1068462046110684620461101000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10)Marketed from Jun 30, 2023
68462-461-30684620461306846204613030 TABLET, FILM COATED in 1 BOTTLE (68462-461-30)Marketed from Aug 13, 2010
68462-461-60684620461606846204616060 TABLET, FILM COATED in 1 BOTTLE (68462-461-60)Marketed from Aug 13, 2010

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)
Trospium Chloride
Generic name (nonproprietary)
trospium chloride
Active ingredients
Trospium chloride — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091575
Marketing start
Listing expires
Other FDA classes
Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 68462-461_44d944da-d624-4016-a3eb-ce810b62fb17SPL ID 44d944da-d624-4016-a3eb-ce810b62fb17SPL set ID d5c837a4-d1c6-4615-b7ad-27f3162a03aaRxCUI 857560UNII 1E6682427EUPC 0368462461600
Pharmacologic class
Cholinergic Muscarinic Antagonist

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

N468462046105 followed by a unit qualifier and the quantity

Package 68462-0461-05. 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)

Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-461

What is NDC 68462-461?
68462-461 is the product NDC for Trospium Chloride, Trospium chloride 20 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Trospium Chloride.
What is the active ingredient?
Trospium chloride.
Who is the labeler?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trospium Chloride?
23 other product NDCs are listed under this name. See all Trospium Chloride 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 Trospium Chloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Trospium ChlorideTrospium chloride 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-476870518-4768-00
Trospium ChlorideTrospium chloride 20 mg/1Tablet, Film coatedOralMAJOR PHARMACEUTICALS0904-761900904-7619-4000904-7619-52
Trospium ChlorideTrospium chloride 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-459370518-4593-0070518-4593-0270518-4593-03+1 more
Trospium ChlorideTrospium chloride 20 mg/1TabletOralMacleods Pharmaceuticals Limited33342-55433342-0554-0933342-0554-39
Trospium ChlorideTrospium chloride 20 mg/1Tablet, Film coatedOralZameer Pharmaceuticals LLC90096-14190096-0141-60
Trospium ChlorideTrospium chloride 60 mg/1Capsule, Extended releaseOralSlate Run Pharmaceuticals, LLC70436-17470436-0174-04
Trospium ChlorideTrospium chloride 60 mg/1Capsule, Extended releaseOralGranules Pharmaceuticals Inc.70010-02770010-0027-0370010-0027-05
Trospium ChlorideTrospium chloride 60 mg/1Capsule, Extended releaseOralProficient Rx LP71205-91771205-0917-0071205-0917-3071205-0917-55+3 more
Trospium ChlorideTrospium chloride 60 mg/1Capsule, Extended releaseOralBluepoint Laboratories68001-42768001-0427-04
Trospium ChlorideTrospium chloride 20 mg/1Tablet, Film coatedOralExelan Pharmaceuticals Inc.76282-33676282-0336-60

All 24 Trospium Chloride NDCs

Other NDCs under ANDA 091575

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

FDA NDC Directory listings under ANDA 091575
ProductStrengthForm · routeLabelerProduct NDC
Trospium ChlorideTrospium chloride 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4768

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