What is NDC 69097-912?

69097-912 is the product NDC for Trospium Chloride, Trospium chloride 20 mg/1 tablet, film coated, listed with the FDA by CIPLA USA INC.,. It has 3 package NDCs, shown above in 10- and 11-digit form.

CIPLA USA INC.,, NDC labeler code 69097. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trospium Chloride NDC 69097-912 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-912Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0912Add 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
69097-912-02	6909709120269097091202	30 TABLET, FILM COATED in 1 BOTTLE (69097-912-02)Marketed from Sep 23, 2016
69097-912-03	6909709120369097091203	60 TABLET, FILM COATED in 1 BOTTLE (69097-912-03)Marketed from Sep 23, 2016
69097-912-15	6909709121569097091215	1000 TABLET, FILM COATED in 1 BOTTLE (69097-912-15)Marketed from Sep 23, 2016

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: CIPLA USA INC.,NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091688
Marketing start: Sep 23, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 69097-912_9058b0be-0e24-418e-9be7-597c00fe8b70SPL ID 9058b0be-0e24-418e-9be7-597c00fe8b70SPL set ID 6a711666-9e80-4728-b745-e7dc86f57510RxCUI 857560UNII 1E6682427E
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

N469097091202 followed by a unit qualifier and the quantity

Package 69097-0912-02. 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 3, 2020.

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 69097-912

What is NDC 69097-912?: 69097-912 is the product NDC for Trospium Chloride, Trospium chloride 20 mg/1 tablet, film coated, listed with the FDA by CIPLA USA INC.,. It has 3 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?: CIPLA USA INC.,, NDC labeler code 69097. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Trospium Chloride	Trospium chloride 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4768	70518-4768-00
Trospium Chloride	Trospium chloride 20 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7619	00904-7619-4000904-7619-52
Trospium Chloride	Trospium chloride 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4593	70518-4593-0070518-4593-0270518-4593-03+1 more
Trospium Chloride	Trospium chloride 20 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-554	33342-0554-0933342-0554-39
Trospium Chloride	Trospium chloride 20 mg/1	Tablet, Film coatedOral	Zameer Pharmaceuticals LLC	90096-141	90096-0141-60
Trospium Chloride	Trospium chloride 60 mg/1	Capsule, Extended releaseOral	Slate Run Pharmaceuticals, LLC	70436-174	70436-0174-04
Trospium Chloride	Trospium chloride 60 mg/1	Capsule, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-027	70010-0027-0370010-0027-05
Trospium Chloride	Trospium chloride 60 mg/1	Capsule, Extended releaseOral	Proficient Rx LP	71205-917	71205-0917-0071205-0917-3071205-0917-55+3 more
Trospium Chloride	Trospium chloride 60 mg/1	Capsule, Extended releaseOral	Bluepoint Laboratories	68001-427	68001-0427-04
Trospium Chloride	Trospium chloride 20 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals Inc.	76282-336	76282-0336-60

All 24 Trospium Chloride NDCs

Other NDCs under ANDA 091688

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

FDA NDC Directory listings under ANDA 091688
Product	Strength	Form · route	Labeler	Product NDC
Trospium Chloride	Trospium chloride 20 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals Inc.	76282-336