Over-the-counter drug · ANDA

Loperamide Hydrochloride NDC 63868-338

Loperamide hydrochloride 2 mg/1 · Tablet · Oral · Chain Drug Marketing Association Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)63868-338Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0338Add 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
63868-338-12638680338126386803381212 TABLET in 1 BLISTER PACK (63868-338-12)Marketed from Feb 1, 1993
63868-338-24638680338246386803382424 TABLET in 1 BLISTER PACK (63868-338-24)Marketed from Feb 1, 1993
63868-338-60638680338606386803386060 TABLET in 1 BOTTLE (63868-338-60)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
Labeler
Chain Drug Marketing Association Inc.NDC labeler code 63868
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 63868-338_0ea72333-af5b-8141-e063-6294a90afe55SPL ID 0ea72333-af5b-8141-e063-6294a90afe55SPL set ID 237b845b-0f02-410d-9750-c95123e6142dRxCUI 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

N463868033812 followed by a unit qualifier and the quantity

Package 63868-0338-12. 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)

About NDC 63868-338

What is NDC 63868-338?
63868-338 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by Chain Drug Marketing Association Inc.. It has 3 package NDCs, 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?
Chain Drug Marketing Association Inc., NDC labeler code 63868. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralYYBA CORP73581-17773581-0177-02
Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-04872288-0048-34
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralYYBA CORP73581-17573581-0175-24
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralCardinal Health 107, LLC55154-027755154-0277-00
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralAurobindo Pharma Limited84386-11784386-0117-24
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralCoupler LLC67046-167667046-1676-03
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralDOLGENCORP INC55910-15555910-0155-55
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralSafecor Health LLC48433-06348433-0063-20
Loperamide Hydrochlorideloperamide hydrochloride oralLoperamide hydrochloride 1 mg/7.5mLSolutionOralBionpharma Inc.69452-40569452-0405-5569452-0405-93
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralSportpharm LLC85766-15485766-0154-0685766-0154-12

All 75 Loperamide Hydrochloride NDCs

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
Anti-Diarrhealloperamide hciLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.29485-9286
Anti-Diarrheal, Caseys 4goodloperamide hclLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-6359
Anti-Diarrheal, Circle Kloperamide hcl tabletLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-5529
Anti-Diarrheal, CVP HEALTHloperamide hclLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-6559
Handy Solutions Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralNavajo Manufacturing Company Inc.67751-162
Lil Drug Store Anti-Diarrhealloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralLil' Drug Store Products, Inc.66715-9859
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralZee Medical Inc35418-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralOhm Laboratories Inc.51660-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralDiscount Drug Mart53943-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralFred's Inc.55315-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralProficient Rx LP63187-462
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralValu Merchandisers Company63941-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralChain Drug Consortium, LLC68016-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralMarc Glassman, Inc.68998-123
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1TabletOralSportpharm LLC85766-154
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralUnifirst First Aid Corporation47682-200
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralUnifirst First Aid Corporation47682-400
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralProficient Rx LP71205-316
MEDIQUE Diamodeloperamide hydrochlorideLoperamide hydrochloride 2 mg/1TabletOralSportpharm LLC85766-120
Private Label Distributorloperamide hcl 2 mgLoperamide hydrochloride 2 mg/1TabletOralUnifirst First Aid Corporation47682-021

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