What is NDC 0591-3636?

0591-3636 is the product NDC for Trospium Chloride, Trospium chloride 60 mg/1 capsule, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. 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 0591-3636 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-3636Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-3636Add 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	Copy
0591-3636-30	0059136363000591363630	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-30)Marketed from Oct 12, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 60 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091289
Marketing start: Oct 12, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0591-3636_1bc1f468-eb7e-4505-9ab8-a9074ac68505SPL ID 1bc1f468-eb7e-4505-9ab8-a9074ac68505
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

N400591363630 followed by a unit qualifier and the quantity

Package 00591-3636-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0591-3636

What is NDC 0591-3636?: 0591-3636 is the product NDC for Trospium Chloride, Trospium chloride 60 mg/1 capsule, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, 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?: Actavis Pharma, Inc., NDC labeler code 0591. 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 091289

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

FDA NDC Directory listings under ANDA 091289
Product	Strength	Form · route	Labeler	Product NDC
Trospium Chloride	Trospium chloride 60 mg/1	Capsule, Extended releaseOral	Golden State Medical Supply, Inc.	60429-098