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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66213-421IInactivated by FDA2026-10-05
excluded packagepackage66213-42166213-421-10IInactivated by FDA2026-10-05
excluded packagepackage66213-42166213-421-50IInactivated by FDA2026-10-05

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 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66213-421-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66213-421-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66213-421-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66213-421-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66213-421-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66213-421-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66213-421-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66213-421-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66213-421-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66213-421-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66213-421-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66213-421-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66213-421-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66213-421-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66213-421-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66213-421-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66213-421-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66213-421-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66213-421-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66213-421-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66213-421-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66213-421-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66213-421-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66213-421-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66213-421-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66213-421-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66213-421-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66213-421-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66213-421-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66213-421-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66213-421-10fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66213-421-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66213-421-1086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66213-421-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66213-421-10bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66213-421-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66213-421-108dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66213-421-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66213-421-10e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66213-421-50e2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
66213-421-102020-01-31C16284748780-19d75b9d0-de9a-f424-e053-dadaa90a57ceDonnatal Extentabs
66213-421-502020-01-31C16284748780-19d75b9d0-de9a-f424-e053-dadaa90a57ceDonnatal Extentabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66213-421-10Donnatal Extentabs100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1001
66213-421-50Donnatal Extentabs500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66213-421-10EA - Each66213-42148f317df-7ae5-4a80-8303-111e6576742412012-07-24
66213-421-50EA - Each66213-421f172a009-1973-4e35-899b-021b2a230d7712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
PhenobarbitalACTIVE INGREDIENTYQE403BP4DDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
SCOPOLAMINE HYDROBROMIDEACTIVE INGREDIENT451IFR0GXBDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
ATROPINEACTIVE MOIETY7C0697DR9IDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
PhenobarbitalACTIVE MOIETYYQE403BP4DDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
SCOPOLAMINEACTIVE MOIETYDL48G20X8XDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
CALCIUM SULFATE, UNSPECIFIEDINACTIVE INGREDIENTWAT0DDB505DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DONNATAL 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
NDCDashboard titleSPL versionValidationDashboard ZIP
66213-421DONNATAL EXTENTABS (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET, FILM COATED, EXTENDED RELEASE [PBM PHARMACEUTICALS, INC]1Legacy NDC, 2 package rows20111017_2064014b-6f8e-4232-88c2-d1870042abc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046997atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / PHENobarbital 48.6 MG / scopolamine HBr 0.0195 MG Extended Release Oral TabletPSN2064014b-6f8e-4232-88c2-d1870042abc71
1046999Donnatal Extentabs 0.0582 MG / 0.311 MG / 48.6 MG / 0.0195 MG Extended Release Oral TabletPSN2064014b-6f8e-4232-88c2-d1870042abc71
1046999atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / phenobarbital 48.6 MG / scopolamine hydrobromide 0.0195 MG Extended Release Oral Tablet [Donnatal]SBD2064014b-6f8e-4232-88c2-d1870042abc71
1046997atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / phenobarbital 48.6 MG / scopolamine hydrobromide 0.0195 MG Extended Release Oral TabletSCD2064014b-6f8e-4232-88c2-d1870042abc71
1046999Donnatal (atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / phenobarbital 48.6 MG / scopolamine hydrobromide 0.0195 MG) Extended Release Oral TabletSY2064014b-6f8e-4232-88c2-d1870042abc71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66213-421-1066213042110100 in 1 BOTTLE, PLASTICHistorical
66213-421-5066213042150500 in 1 BOTTLE, PLASTICHistorical