Donnatal NDC 59212-423

NDC codes

FDA NDC Directory

Product NDC (as listed)59212-423Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59212-0423Add 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
59212-423-04	59212042304	118 mL in 1 BOTTLE (59212-423-04)Marketed from Dec 30, 1980
59212-423-10	59212042310	10 mL in 1 BOTTLE (59212-423-10)Marketed from Dec 30, 1980
59212-423-16	59212042316	473 mL in 1 BOTTLE (59212-423-16)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/5mLHyoscyamine sulfate — .1037 mg/5mLAtropine sulfate — .0194 mg/5mLScopolamine hydrobromide — .0065 mg/5mL
Dosage form: Elixir
Route: Oral
Labeler: Advanz Pharma (US) Corp.
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 59212-423_f15ad820-c07e-4e6b-a154-7ddca20bc838SPL ID f15ad820-c07e-4e6b-a154-7ddca20bc838SPL set ID 4dba30db-7979-455f-a225-24f0a04d744eRxCUI 1046787, 1046924UNII F2R8V82B84, 03J5ZE7KA5, YQE403BP4D, 451IFR0GXBUPC 0359212423047
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

N459212042304 followed by a unit qualifier and the quantity

Package 59212-0423-04. 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)