What is NDC 43598-770?

43598-770 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, liquid filled, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Loperamide Hydrochloride?

74 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Loperamide Hydrochloride NDC 43598-770

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-770Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0770Add 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
43598-770-24	4359807702443598077024	2 BLISTER PACK in 1 CARTON (43598-770-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 1, 2023

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): Loperamide Hydrochloride
Generic name (nonproprietary): loperamide hydrochloride
Active ingredients: Loperamide hydrochloride — 2 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213070
Marketing start: Oct 22, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 43598-770_9e844085-911a-6aff-3f42-27056b1de246SPL ID 9e844085-911a-6aff-3f42-27056b1de246SPL set ID 6fe91ddc-06b6-3a51-2b48-f6f11361ab73RxCUI 978006UNII 77TI35393C
Pharmacologic class: Opioid Agonist

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

N443598077024 followed by a unit qualifier and the quantity

Package 43598-0770-24. 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 Jun 25, 2023.

Indications (excerpt from the label)

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-770

What is NDC 43598-770?: 43598-770 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, liquid filled, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loperamide Hydrochloride.
What is the active ingredient?: Loperamide hydrochloride.
Who is the labeler?: Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Loperamide Hydrochloride?: 74 other product NDCs are listed under this name. See all Loperamide 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 Loperamide Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	Capsule, Liquid filledOral	YYBA CORP	73581-177	73581-0177-02
Loperamide Hydrochlorideloperamide hcl	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Amazon.com Services LLC	72288-048	72288-0048-34
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	YYBA CORP	73581-175	73581-0175-24
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0277	55154-0277-00
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Aurobindo Pharma Limited	84386-117	84386-0117-24
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Coupler LLC	67046-1676	67046-1676-03
Loperamide Hydrochloride	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	DOLGENCORP INC	55910-155	55910-0155-55
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	CapsuleOral	Safecor Health LLC	48433-063	48433-0063-20
Loperamide Hydrochlorideloperamide hydrochloride oral	Loperamide hydrochloride 1 mg/7.5mL	SolutionOral	Bionpharma Inc.	69452-405	69452-0405-5569452-0405-93
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	TabletOral	Sportpharm LLC	85766-154	85766-0154-0685766-0154-12

All 75 Loperamide Hydrochloride NDCs

Other NDCs under ANDA 213070

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

FDA NDC Directory listings under ANDA 213070
Product	Strength	Form · route	Labeler	Product NDC
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	Capsule, Liquid filledOral	Strides Pharma, Inc.	59556-959
Loperamide Hydrochloride	Loperamide hydrochloride 2 mg/1	Capsule, Liquid filledOral	Dr. Reddy's Laboratories Inc.	75907-097