What is NDC 59212-425?

59212-425 is the product NDC for Donnatal, Phenobarbital 16.2 mg/1 + 3 more ingredients tablet, listed with the FDA by Advanz Pharma (US) Corp.. It has 2 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.

Advanz Pharma (US) Corp., NDC labeler code 59212. 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 59212-425 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59212-425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59212-0425Add 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
59212-425-04	5921204250459212042504	4 TABLET in 1 BOTTLE, PLASTIC (59212-425-04)Marketed from Dec 30, 1980
59212-425-10	5921204251059212042510	100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10)Marketed from Dec 30, 1980

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/1Hyoscyamine sulfate — .1037 mg/1Atropine sulfate — .0194 mg/1Scopolamine hydrobromide — .0065 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanz Pharma (US) Corp.NDC labeler code 59212
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Dec 30, 1980
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 59212-425_0395fab5-b3e6-4822-872c-16002ae8ff58SPL ID 0395fab5-b3e6-4822-872c-16002ae8ff58SPL set ID c93cccdc-2f92-4cb3-9d14-06acdd51d94cRxCUI 1046815, 1046978UNII YQE403BP4D, F2R8V82B84, 03J5ZE7KA5, 451IFR0GXBUPC 0359212425102
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

N459212042504 followed by a unit qualifier and the quantity

Package 59212-0425-04. 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 Dec 5, 2024.

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 59212-425

What is NDC 59212-425?: 59212-425 is the product NDC for Donnatal, Phenobarbital 16.2 mg/1 + 3 more ingredients tablet, listed with the FDA by Advanz Pharma (US) Corp.. It has 2 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?: Advanz Pharma (US) Corp., NDC labeler code 59212. 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	VistaPharm, LLC	66689-063	66689-0063-1066689-0063-4066689-0063-50+1 more
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