NDC codes

FDA NDC Directory
Product NDC (as listed)75907-097Labeler and product segments. Claims need a package NDC.
Product NDC at billing width75907-0097Add 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
75907-097-1275907009712759070097121 BLISTER PACK in 1 CARTON (75907-097-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 1, 2023
75907-097-2475907009724759070097242 BLISTER PACK in 1 CARTON (75907-097-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 1, 2023

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
Capsule, Liquid filled
Route
Oral
Labeler
Dr. Reddy's Laboratories Inc.NDC labeler code 75907
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213070
Marketing start
Listing expires
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 75907-097_cefb1fd9-768f-c7a4-b9b1-ab7faaa67308SPL ID cefb1fd9-768f-c7a4-b9b1-ab7faaa67308SPL set ID 356d9432-d948-4b88-b297-9161b845f86bRxCUI 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

N475907009712 followed by a unit qualifier and the quantity

Package 75907-0097-12. 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 75907-097

What is NDC 75907-097?
75907-097 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, liquid filled, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 2 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?
Dr. Reddy's Laboratories Inc., NDC labeler code 75907. 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 213070

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

FDA NDC Directory listings under ANDA 213070
ProductStrengthForm · routeLabelerProduct NDC
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralDr. Reddy's Laboratories Inc.43598-770
Loperamide HydrochlorideLoperamide hydrochloride 2 mg/1Capsule, Liquid filledOralStrides Pharma, Inc.59556-959

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