What is NDC 43386-660?

43386-660 is the product NDC for Trimethobenzamide Hydrochloride, Trimethobenzamide hydrochloride 300 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Trimethobenzamide Hydrochloride?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trimethobenzamide Hydrochloride NDC 43386-660

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-660Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0660Add 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
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.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076546
Marketing start: Jan 17, 2011
Listing expires: Dec 31, 2026
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

N443386066003 followed by a unit qualifier and the quantity

Package 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 Jan 30, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 43386-660

What is NDC 43386-660?: 43386-660 is the product NDC for Trimethobenzamide Hydrochloride, Trimethobenzamide hydrochloride 300 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Trimethobenzamide Hydrochloride.
What is the active ingredient?: Trimethobenzamide hydrochloride.
Who is the labeler?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trimethobenzamide Hydrochloride?: 4 other product NDCs are listed under this name. See all Trimethobenzamide Hydrochloride 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 Trimethobenzamide Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Trimethobenzamide Hydrochloride	Trimethobenzamide hydrochloride 100 mg/mL	InjectionIntramuscular	BPI Labs, LLC	54288-158	54288-0158-25
Trimethobenzamide Hydrochloride	Trimethobenzamide hydrochloride 300 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-180	23155-0180-01
Trimethobenzamide Hydrochloride	Trimethobenzamide hydrochloride 300 mg/1	CapsuleOral	Chartwell RX, LLC	62135-773	62135-0773-3062135-0773-90
Trimethobenzamide Hydrochloride	Trimethobenzamide hydrochloride 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0800	71335-0800-0171335-0800-0271335-0800-03

Other NDCs under ANDA 076546

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

FDA NDC Directory listings under ANDA 076546
Product	Strength	Form · route	Labeler	Product NDC
Trimethobenzamide Hydrochloride	Trimethobenzamide hydrochloride 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0800