Over-the-counter drug · ANDA

Loperamide Hydrochloride NDC 68016-123

Loperamide hydrochloride 2 mg/1 · Tablet · Oral · Chain Drug Consortium, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)68016-123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68016-0123Add 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
68016-123-06680160123066 TABLET in 1 BLISTER PACK (68016-123-06)Marketed from Feb 1, 1993
68016-123-186801601231818 TABLET in 1 BLISTER PACK (68016-123-18)Marketed from Feb 1, 1993
68016-123-246801601232424 TABLET in 1 BLISTER PACK (68016-123-24)Marketed from Feb 1, 1993
68016-123-976801601239796 TABLET in 1 BOTTLE (68016-123-97)Marketed from Feb 1, 1993

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
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074091
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 68016-123_0ea714a1-b048-bc87-e063-6294a90a28e7SPL ID 0ea714a1-b048-bc87-e063-6294a90a28e7SPL set ID b070896b-1e22-41d4-a66d-8d3be1699217RxCUI 978010UNII 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

N468016012306 followed by a unit qualifier and the quantity

Package 68016-0123-06. 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 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)

Other NDCs under ANDA 074091

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

FDA NDC Directory listings under ANDA 074091
ProductStrengthForm · routeLabelerProduct NDC
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralOhm Laboratories Inc.51660-123
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralProficient Rx LP71205-316
Anti-Diarrheal, Circle Kloperamide hcl tabletLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-5529
Private Label Distributorloperamide hcl 2 mgLoperamide hydrochloride 2 mg/1TabletOralUnifirst First Aid Corporation47682-021
Anti-Diarrheal, Caseys 4goodloperamide hclLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-6359
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralValu Merchandisers Company63941-123
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralUnifirst First Aid Corporation47682-200
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralFred's Inc.55315-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralDiscount Drug Mart53943-123
Anti-Diarrheal, CVP HEALTHloperamide hclLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-6559
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralChain Drug Marketing Association Inc.63868-338
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralMedline Industries, LP53329-664
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralProficient Rx LP63187-462
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralSportpharm LLC85766-120
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralMarc Glassman, Inc.68998-123
Handy Solutions Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralNavajo Manufacturing Company Inc.67751-162
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralUnifirst First Aid Corporation47682-400
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralZee Medical Inc35418-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralSportpharm LLC85766-154
Anti-Diarrhealloperamide hciLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.29485-9286

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