The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Donnatal
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide · PHENOBARBITAL 16.2 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; ATROPINE SULFATE .0194 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 · Tablet · Oral · Advanz Pharma (US) Corp.
NDC 59212-0425-04 · 4 TABLET in 1 BOTTLE, PLASTIC · UNAPPROVED DRUG OTHER · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Regulatory
- Application
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- TE code
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- Approval date
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- Patents / exclusivity
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Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class III · TerminatedOct 13, 2015Rx PAK — Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Manufacturers of Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Advanz Pharma (US) Corp. | PHENOBARBITAL 16.2 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; ATROPINE SULFATE .0194 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Winder Laboratories, LLC | PHENOBARBITAL 16.2 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; ATROPINE SULFATE .0194 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Advanz Pharma (US) Corp. | PHENOBARBITAL .0194 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; ATROPINE SULFATE 16.2 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Winder Laboratories, LLC | PHENOBARBITAL .0194 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; ATROPINE SULFATE 16.2 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Advanz Pharma (US) Corp. | ATROPINE SULFATE .0194 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; PHENOBARBITAL 16.2 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Winder Laboratories, LLC | ATROPINE SULFATE .0194 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; PHENOBARBITAL 16.2 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Donnatal — NDC 59212-0425-04," retrieved September 3, 2026, https://drugdashboards.com/drug/59212042504.
Free to cite with attribution — see how the data is put together.