What is NDC 66689-063?

66689-063 is the product NDC for Donnatal, Phenobarbital 16.2 mg/5mL + 3 more ingredients elixir, listed with the FDA by VistaPharm, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Donnatal (Phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide).

What is the active ingredient?

Phenobarbital, Hyoscyamine sulfate, Atropine sulfate, Scopolamine hydrobromide.

VistaPharm, LLC, NDC labeler code 66689. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Donnatal?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Donnatal NDC 66689-063 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)66689-063Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66689-0063Add 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
66689-063-10	6668900631066689006310	1 TRAY in 1 CASE (66689-063-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)Marketed from Oct 26, 2017
66689-063-40	6668900634066689006340	4 TRAY in 1 CASE (66689-063-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)Marketed from Oct 26, 2017
66689-063-50	6668900635066689006350	5 TRAY in 1 CASE (66689-063-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)Marketed from Oct 26, 2017
66689-063-99	6668900639966689006399	10 TRAY in 1 CASE (66689-063-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)Marketed from Oct 26, 2017

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): Donnatal
Generic name (nonproprietary): phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Active ingredients: Phenobarbital — 16.2 mg/5mLHyoscyamine sulfate — .1037 mg/5mLAtropine sulfate — .0194 mg/5mLScopolamine hydrobromide — .0065 mg/5mL
Dosage form: Elixir
Route: Oral
Labeler: VistaPharm, LLCNDC labeler code 66689
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Oct 26, 2017
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 66689-063_b528eb39-f078-452f-939c-2daebd4d70ffSPL ID b528eb39-f078-452f-939c-2daebd4d70ffSPL set ID 11a48ba9-576b-4e8c-9536-6e83636d6930RxCUI 1046787, 1046924UNII YQE403BP4D, F2R8V82B84, 03J5ZE7KA5, 451IFR0GXB
Pharmacologic class: Anticholinergic; Cholinergic Muscarinic Antagonist

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

N466689006310 followed by a unit qualifier and the quantity

Package 66689-0063-10. 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 Jul 7, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. Final classification of the less-than-effective indications requires further investigation. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICAT…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66689-063

What is NDC 66689-063?: 66689-063 is the product NDC for Donnatal, Phenobarbital 16.2 mg/5mL + 3 more ingredients elixir, listed with the FDA by VistaPharm, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Donnatal (Phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide).
What is the active ingredient?: Phenobarbital, Hyoscyamine sulfate, Atropine sulfate, Scopolamine hydrobromide.
Who is the labeler?: VistaPharm, LLC, NDC labeler code 66689. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Donnatal?: 3 other product NDCs are listed under this name. See all Donnatal 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 Donnatal NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Donnatalphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide	Phenobarbital 16.2 mg/5mL + 3 more ingredients	ElixirOral	Advanz Pharma (US) Corp.	59212-422	59212-0422-0459212-0422-1059212-0422-16
Donnatalphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide	Phenobarbital 16.2 mg/5mL + 3 more ingredients	ElixirOral	Advanz Pharma (US) Corp.	59212-423	59212-0423-0459212-0423-1059212-0423-16
Donnatalphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide	Phenobarbital 16.2 mg/1 + 3 more ingredients	TabletOral	Advanz Pharma (US) Corp.	59212-425	59212-0425-0459212-0425-10