FDA.reportPublic FDA data

Donnatal

Product NDC
42254-268
11-digit product format
422540268
Labeler code
42254
Product ID
42254-268_1cc18146-d9be-4975-89ba-e99a85f71c76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-05-07
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-268-202019-09-24C16284748780-19350213a-3c5c-c013-e053-90daa90a1393Donnatal Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-268-20Donnatal20 in 1 BOTTLE, PLASTICTABLET201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-268-20EA - Each42254-2680464fc99-ba7a-406c-9164-da5d45795a5f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
PhenobarbitalACTIVE INGREDIENTYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
SCOPOLAMINE HYDROBROMIDEACTIVE INGREDIENT451IFR0GXBDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
ATROPINEACTIVE MOIETY7C0697DR9IDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
PhenobarbitalACTIVE MOIETYYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
SCOPOLAMINEACTIVE MOIETYDL48G20X8XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-268DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20121201_1cc18146-d9be-4975-89ba-e99a85f71c76.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 TabletPSN1cc18146-d9be-4975-89ba-e99a85f71c761
1046978Donnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral TabletPSN1cc18146-d9be-4975-89ba-e99a85f71c761
1046978atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]SBD1cc18146-d9be-4975-89ba-e99a85f71c761
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral TabletSCD1cc18146-d9be-4975-89ba-e99a85f71c761
1046978Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral TabletSY1cc18146-d9be-4975-89ba-e99a85f71c761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-268-204225402682020 in 1 BOTTLE, PLASTICHistorical