NDC 59212-425 – Donnatal
Phenobarbital 16.2 mg/1; Hyoscyamine Sulfate .1037 mg/1; Atropine Sulfate .0194 mg/1; Scopolamine Hydrobromide .0065 mg/1 · Tablet · Oral
Product NDC59212-425
Product details
- Brand name
- Donnatal
- Generic name
- Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
- Labeler
- Advanz Pharma (US) Corp.
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketed since
- December 30, 1980
- Listing expires
- December 31, 2026
- Pharmacologic class
- Anticholinergic; Anticholinergic; Cholinergic Muscarinic Antagonist
Active ingredients
- Phenobarbital 16.2 mg/1
- Hyoscyamine Sulfate .1037 mg/1
- Atropine Sulfate .0194 mg/1
- Scopolamine Hydrobromide .0065 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 59212-425-04 | 4 TABLET in 1 BOTTLE, PLASTIC (59212-425-04) | Dec 30, 1980 |
| 59212-425-10 | 100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10) | Dec 30, 1980 |
Recalls mentioning this NDC
- D-0053-2016 Oct 28, 2015 · Class III
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Other Donnatal products
- 59212-422 Phenobarbital 16.2 mg/5mL; Hyoscyamine Sulfate .1037 mg/5mL; Atropine… · Elixir · Advanz Pharma (US) Corp.
- 59212-423 Phenobarbital 16.2 mg/5mL; Hyoscyamine Sulfate .1037 mg/5mL; Atropine… · Elixir · Advanz Pharma (US) Corp.
- 66689-063 Phenobarbital 16.2 mg/5mL; Hyoscyamine Sulfate .1037 mg/5mL; Atropine… · Elixir · VistaPharm, LLC