NDC codes

FDA NDC Directory
Product NDC (as listed)25000-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25000-0001Add 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 NDC11-digit (billing)PackageCopy
25000-001-8325000000183250000001834 BLISTER PACK in 1 CARTON (25000-001-83) / 6 TABLET in 1 BLISTER PACKMarketed from Nov 19, 2025

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 2mg
Generic name (nonproprietary)
loperamide hydrochloride tablets usp, 2mg
Active ingredients
Loperamide hydrochloride — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
MARKSANS PHARMA LIMITEDNDC labeler code 25000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 220153
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 25000-001_2081729a-e6bb-44b8-8295-b7810b77df5eSPL ID 2081729a-e6bb-44b8-8295-b7810b77df5eSPL set ID 644fb37a-1d97-4333-a5c7-5a485ab338f7RxCUI 978010UNII 77TI35393CUPC 0325000001834
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

N425000000183 followed by a unit qualifier and the quantity

Package 25000-0001-83. 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)

USE(S) 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 25000-001

What is NDC 25000-001?
25000-001 is the product NDC for Loperamide Hydrochloride 2mg, Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by MARKSANS PHARMA LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Loperamide Hydrochloride 2mg (Loperamide Hydrochloride Tablets USP, 2mg).
What is the active ingredient?
Loperamide hydrochloride.
Who is the labeler?
MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 2mg?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 220153

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

FDA NDC Directory listings under ANDA 220153
ProductStrengthForm · routeLabelerProduct NDC
Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1Tablet, Film coatedOralKroger41226-797

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