NDC codes

FDA NDC Directory
Product NDC (as listed)49035-695Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0695Add 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
49035-695-264903506952649035069526118 mL in 1 BOTTLE (49035-695-26)Marketed from Sep 3, 2020

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)
equate diarrhea control
Generic name (nonproprietary)
loperamide hcl
Active ingredients
Loperamide hydrochloride — 1 mg/7.5mL
Dosage form
Suspension
Route
Oral
Labeler
Wal-Mart Stores IncNDC labeler code 49035
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091292
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 49035-695_0e65f9fd-3921-4b26-be5d-8f55c2ba48a0SPL ID 0e65f9fd-3921-4b26-be5d-8f55c2ba48a0SPL set ID 53283496-4e65-40ea-8dfb-851ea2c0cc15RxCUI 1250685UNII 77TI35393CUPC 0681131378734
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

N449035069526 followed by a unit qualifier and the quantity

Package 49035-0695-26. 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 49035-695

What is NDC 49035-695?
49035-695 is the product NDC for equate diarrhea control (loperamide hcl), Loperamide hydrochloride 1 mg/7.5mL suspension, listed with the FDA by Wal-Mart Stores Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
equate diarrhea control (Loperamide HCl).
What is the active ingredient?
Loperamide hydrochloride.
Who is the labeler?
Wal-Mart Stores Inc, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for equate diarrhea control?
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 091292

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

FDA NDC Directory listings under ANDA 091292
ProductStrengthForm · routeLabelerProduct NDC
basic care loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-645
Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralAmazon.com Services LLC72288-048
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralMajor Pharmaceuticals0904-6836
Equate Loperamide Hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralWal-Mart Stores Inc49035-451
basic care loperamide hydrochlorideloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSuspensionOralAmazon.com Services LLC72288-758
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-6836
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralMeijer Distribution Inc41250-813
Loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralCVS Pharmacy69842-191
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralPreferred Pharmaceuticals Inc.68788-7842
leader anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralCardinal Health 110, LLC. dba Leader70000-0417
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralPrecision Dose, Inc.68094-029
leader anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0418
CareOne Diarrhea Controlloperamide hydrochlorideLoperamide hydrochloride 1 mg/7.5mLSuspensionOralAmerican Sales Company41520-841
topcare loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralTopco Associates LLC36800-583
anti diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralH E B37808-449
DG Health Anti Diarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralDolgencorp Inc55910-867
Loperamide HydrochlorideLoperamide hydrochloride 1 mg/7.5mLSolutionOralPrecision Dose, Inc.68094-129
equaline loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralUnited Natural Foods, Inc. dba UNFI41163-210
loperamide hydrochlorideloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralRite Aid Corporation11822-5519
Good Sense antidiarrhealloperamide hclLoperamide hydrochloride 1 mg/7.5mLSolutionOralPreferred Pharmaceuticals Inc.68788-8796

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