Home NDC 42291-245-01 Donnatal
Product NDC 42291-245
Requested package NDC 42291-245-01
11-digit product format 422910245
Labeler code 42291
Product ID 42291-245_d57a0a79-c3c6-3000-e053-2995a90a7c25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
Dosage form TABLET
Route ORAL
Labeler AvKARE
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2014-01-06
Marketing end 0000-00-00
Substance PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE
Active strength 16 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATROPINE SULFATE ACTIVE INGREDIENT 03J5ZE7KA5 DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 HYOSCYAMINE SULFATE ACTIVE INGREDIENT F2R8V82B84 DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 Phenobarbital ACTIVE INGREDIENT YQE403BP4D DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 SCOPOLAMINE HYDROBROMIDE ACTIVE INGREDIENT 451IFR0GXB DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 ATROPINE ACTIVE MOIETY 7C0697DR9I DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 HYOSCYAMINE ACTIVE MOIETY PX44XO846X DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 Phenobarbital ACTIVE MOIETY YQE403BP4D DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 SCOPOLAMINE ACTIVE MOIETY DL48G20X8X DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-245-01 42291024501 100 TABLET in 1 BOTTLE (42291-245-01) 100 tablet 2014-01-06 0000-00-00 No No Current