Prescription drug · ANDA
Trospium Chloride NDC 0904-7619
Trospium chloride 20 mg/1 · Tablet, Film coated · Oral · MAJOR PHARMACEUTICALS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7619-40 | 0090476194000904761940 | 500 TABLET, FILM COATED in 1 BOTTLE (0904-7619-40)Marketed from Aug 27, 2026 | |
| 0904-7619-52 | 0090476195200904761952 | 60 TABLET, FILM COATED in 1 BOTTLE (0904-7619-52)Marketed from Aug 27, 2026 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- MAJOR PHARMACEUTICALSNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204945
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0904-7619_4aa63ad9-907e-4e15-9cd7-b3a589691d98SPL ID 4aa63ad9-907e-4e15-9cd7-b3a589691d98SPL set ID 7a2fea88-266d-4fc0-a476-66dc6effcff7RxCUI 857560UNII 1E6682427EUPC 0309047619405
- 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
N400904761940followed by a unit qualifier and the quantityPackage 00904-7619-40. 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.
About NDC 0904-7619
- What is NDC 0904-7619?
- 0904-7619 is the product NDC for Trospium Chloride, Trospium chloride 20 mg/1 tablet, film coated, listed with the FDA by MAJOR PHARMACEUTICALS. It has 2 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?
- MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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.
Related NDCs: other Trospium Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | CIPLA USA INC., | 69097-912 | 69097-0912-0269097-0912-0369097-0912-15 |
Other NDCs under ANDA 204945
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7059 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-530 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-742 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4593 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-812 |