What is NDC 65197-420?

65197-420 is the product NDC for Emetrol Chewables Mixed Berry (sodium citrate dihydrate), Trisodium citrate dihydrate 230 mg/1 tablet, chewable, 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 Chewables Mixed Berry (Sodium citrate dihydrate).

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 Chewables Mixed Berry?

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.

Emetrol Chewables Mixed Berry NDC 65197-420

NDC codes

FDA NDC Directory

Product NDC (as listed)65197-420Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65197-0420Add 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 NDC	11-digit (billing)	Package	Copy
65197-420-60	6519704206065197042060	1 BOTTLE in 1 BOX (65197-420-60) / 60 TABLET, CHEWABLE in 1 BOTTLEMarketed from Jul 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 Chewables Mixed Berry
Generic name (nonproprietary): sodium citrate dihydrate
Active ingredients: Trisodium citrate dihydrate — 230 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: WellSpring Pharmaceutical CorporationNDC labeler code 65197
Product type: Over-the-counter drug
Marketing category: Unapproved drug (other)
Marketing start: Jul 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 65197-420_35e7ffe9-370b-4d46-8019-737ca7238cc6SPL ID 35e7ffe9-370b-4d46-8019-737ca7238cc6SPL set ID 4965fab0-828d-4f1d-8d43-a636e0a8c1eaRxCUI 2002800, 2596185UNII 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

N465197042060 followed by a unit qualifier and the quantity

Package 65197-0420-60. 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 Mar 23, 2023.

Indications (excerpt from the label)

Uses For the relief of nausea associated with upset/sour 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 65197-420

What is NDC 65197-420?: 65197-420 is the product NDC for Emetrol Chewables Mixed Berry (sodium citrate dihydrate), Trisodium citrate dihydrate 230 mg/1 tablet, chewable, 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 Chewables Mixed Berry (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 Chewables Mixed Berry?: 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.

Emetrol Chewables Mixed Berry (Sodium citrate dihydrate) NDC 65197-420