Home NDC 66213-421 Donnatal Extentabs
Product NDC 66213-421
11-digit product format 662130421
Labeler code 66213
Product ID 66213-421_03a3609f-520f-4e7b-8d7b-1652881723c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler PBM Pharmaceuticals, Inc
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 49 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 2018-12-31
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 2 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66213-421-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66213-421-50 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66213-421-50 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66213-421-10 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66213-421-10 Donnatal Extentabs 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED, EXTENDED RE 100 1 66213-421-50 Donnatal Extentabs 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED, EXTENDED RE 500 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATROPINE SULFATE ACTIVE INGREDIENT 03J5ZE7KA5 DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 HYOSCYAMINE SULFATE ACTIVE INGREDIENT F2R8V82B84 DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 Phenobarbital ACTIVE INGREDIENT YQE403BP4D DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 SCOPOLAMINE HYDROBROMIDE ACTIVE INGREDIENT 451IFR0GXB DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 ATROPINE ACTIVE MOIETY 7C0697DR9I DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 HYOSCYAMINE ACTIVE MOIETY PX44XO846X DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 Phenobarbital ACTIVE MOIETY YQE403BP4D DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 SCOPOLAMINE ACTIVE MOIETY DL48G20X8X DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 CALCIUM SULFATE, UNSPECIFIED INACTIVE INGREDIENT WAT0DDB505 DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 HYPROMELLOSE 2208 (4000 MPA.S) INACTIVE INGREDIENT 39J80LT57T DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 POLYETHYLENE GLYCOL 2000 INACTIVE INGREDIENT HAF0412YIT DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66213-421 DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC] 1 Legacy NDC, 2 package rows 20111017_2064014b-6f8e-4232-88c2-d1870042abc7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66213-421-10 66213042110 100 in 1 BOTTLE, PLASTIC Historical 66213-421-50 66213042150 500 in 1 BOTTLE, PLASTIC Historical