NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2487Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2487Add 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
71335-2487-0713352487007133524870050 CAPSULE in 1 BOTTLE (71335-2487-0)Marketed from Sep 18, 2024
71335-2487-1713352487017133524870115 CAPSULE in 1 BOTTLE (71335-2487-1)Marketed from Sep 18, 2024
71335-2487-2713352487027133524870230 CAPSULE in 1 BOTTLE (71335-2487-2)Marketed from Sep 18, 2024
71335-2487-3713352487037133524870320 CAPSULE in 1 BOTTLE (71335-2487-3)Marketed from Sep 18, 2024
71335-2487-4713352487047133524870412 CAPSULE in 1 BOTTLE (71335-2487-4)Marketed from Sep 18, 2024
71335-2487-5713352487057133524870560 CAPSULE in 1 BOTTLE (71335-2487-5)Marketed from Sep 18, 2024
71335-2487-6713352487067133524870624 CAPSULE in 1 BOTTLE (71335-2487-6)Marketed from Sep 18, 2024
71335-2487-7713352487077133524870714 CAPSULE in 1 BOTTLE (71335-2487-7)Marketed from Sep 18, 2024
71335-2487-871335248708713352487089 CAPSULE in 1 BOTTLE (71335-2487-8)Marketed from Sep 18, 2024
71335-2487-971335248709713352487095 CAPSULE in 1 BOTTLE (71335-2487-9)Marketed from Sep 18, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216876
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 71335-2487_e99e3001-97ad-4342-93b3-b66d83c15c85SPL ID e99e3001-97ad-4342-93b3-b66d83c15c85SPL set ID a2594967-e737-4a23-a710-290ca0e6a272RxCUI 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

N471335248700 followed by a unit qualifier and the quantity

Package 71335-2487-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2487

What is NDC 71335-2487?
71335-2487 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 216876

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

FDA NDC Directory listings under ANDA 216876
ProductStrengthForm · routeLabelerProduct NDC
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8497
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1CapsuleOralAdvagen Pharma Ltd.,72888-130

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