Prescription drug · ANDA
Trimethobenzamide Hydrochloride NDC 43386-660
Trimethobenzamide hydrochloride 300 mg/1 · Capsule · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-660-03 | 43386066003 | 30 CAPSULE in 1 BOTTLE (43386-660-03)Marketed from Jan 17, 2011 | |
| 43386-660-24 | 43386066024 | 100 CAPSULE in 1 BOTTLE (43386-660-24)Marketed from Jan 17, 2011 |
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)
- Trimethobenzamide Hydrochloride
- Generic name (nonproprietary)
- trimethobenzamide hydrochloride
- Active ingredients
- Trimethobenzamide hydrochloride — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076546
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 43386-660_49c03212-c2eb-49b8-bc11-bbfd75122965SPL ID 49c03212-c2eb-49b8-bc11-bbfd75122965SPL set ID c18073be-d52a-4347-a8d1-6be11bcb7824RxCUI 860771UNII WDQ5P1SX7QUPC 0343386660247
- Pharmacologic class
- Antiemetic
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
N443386066003followed by a unit qualifier and the quantityPackage 43386-0660-03. 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)
Trimethobenzamide hydrochloride capsules is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. Limitation of Use: Trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects, and the risk of exacerbation of the underlying disease in pediatric patients with Reye's syndrome or other hepatic impairment. Trimethobenzamide hydrochloride capsules are an antiemetic indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. ( 1 ) …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076546
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 |
|---|---|---|---|---|
| Trimethobenzamide Hydrochloride | Trimethobenzamide hydrochloride 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0800 |
- openFDA data updated
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