NDC codes

FDA NDC Directory
Product NDC (as listed)65197-203Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65197-0203Add 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
65197-203-0965197020309651970203096 POWDER, FOR SOLUTION in 1 CARTON (65197-203-09)Marketed from Dec 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)
Emetrol Powder Non-DrowsySuffix: Non-Drowsy
Generic name (nonproprietary)
sodium citrate dihydrate
Active ingredients
Trisodium citrate dihydrate — 460 mg/1
Dosage form
Powder, For solution
Route
Oral
Labeler
WellSpring Pharmaceutical CorporationNDC labeler code 65197
Product type
Over-the-counter drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers
Product ID 65197-203_a6121b17-e850-4677-9ad1-ceb36de16336SPL ID a6121b17-e850-4677-9ad1-ceb36de16336SPL set ID 9d8d2ee7-9db7-4be7-8c73-511eb2e32459RxCUI 2671573, 2671579UNII B22547B95K
Pharmacologic class
Anti-coagulant; Calculi Dissolution Agent

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

N465197020309 followed by a unit qualifier and the quantity

Package 65197-0203-09. 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)

Uses For the relief of nausea associated with upset stomach, including that due to overindulgence in food and drink.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65197-203

What is NDC 65197-203?
65197-203 is the product NDC for Emetrol Powder Non-Drowsy (sodium citrate dihydrate), Trisodium citrate dihydrate 460 mg/1 powder, for solution, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Emetrol Powder Non-Drowsy (Sodium Citrate Dihydrate).
What is the active ingredient?
Trisodium citrate dihydrate.
Who is the labeler?
WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Emetrol Powder Non-Drowsy?
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.

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