FDA.reportPublic FDA data

Donnatal

Product NDC
59212-425
11-digit product format
592120425
Labeler code
59212
Product ID
59212-425_0395fab5-b3e6-4822-872c-16002ae8ff58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1980-12-30
Substance
ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength
.0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donnatal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.0194 mg/1
HYOSCYAMINE SULFATE.1037 mg/1
PHENOBARBITAL16.2 mg/1
SCOPOLAMINE HYDROBROMIDE.0065 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5, F2R8V82B84, YQE403BP4D, 451IFR0GXB
Rxcui1046815, 1046978

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59212-425-04Donnatal04 in 1 BOTTLE, PLASTICTABLET0414
59212-425-10Donnatal100 in 1 BOTTLE, PLASTICTABLET10014
59212-425-11Donnatal1000 in 1 BOTTLE, PLASTICTABLET100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-425-10EA - Each59212-4253a55d886-12c4-4343-81ac-4fcfa89105f112015-03-03
59212-425-11EA - Each59212-4252d176477-460f-4a1c-88dc-8f3f7538223112015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
PHENOBARBITALACTIVE INGREDIENTYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
SCOPOLAMINE HYDROBROMIDEACTIVE INGREDIENT451IFR0GXBDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
ATROPINEACTIVE MOIETY7C0697DR9IDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
HYOSCYAMINEACTIVE MOIETYPX44XO846XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
PHENOBARBITALACTIVE MOIETYYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
SCOPOLAMINEACTIVE MOIETYDL48G20X8XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-425DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [ADVANZ PHARMA (US) CORP.]14Current NDC, Legacy NDC, 3 package rows20241224_c93cccdc-2f92-4cb3-9d14-06acdd51d94c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG Oral TabletPSNc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046978Donnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral TabletPSNc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046978atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]SBDc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral TabletSCDc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046978Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral TabletSYc93cccdc-2f92-4cb3-9d14-06acdd51d94c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-425-04592120425044 TABLET in 1 BOTTLE, PLASTIC (59212-425-04) 4 tablet1980-12-300000-00-00NoNoCurrent
59212-425-1059212042510100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10) 100 tablet1980-12-300000-00-00NoNoCurrent
59212-425-11592120425111000 in 1 BOTTLE, PLASTICHistorical