Belladonna and Opium

Product NDC
63629-8436
11-digit product format
636298436
Labeler code
63629
Product ID
63629-8436_580cd487-06dc-4c1b-a312-0042f4e792e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPA BELLADONNA and OPIUM
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1994-05-01
Substance
ATROPA BELLADONNA; OPIUM
Active strength
16.2; 30 mg/1; mg/1
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Belladonna and Opium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPA BELLADONNA16.2 mg/1
OPIUM30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WQZ3G9PF0HInternal UNII lookup
37M3MZ001LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312104Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
088b9cd1-da68-4c34-8f09-62c2cde19e1fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8436-1Belladonna and Opium1 in 1 PACKETSUPPOSITORY1102
63629-8436-1Belladonna and Opium4 in 1 BOXSUPPOSITORY4102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8436BELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240112_088b9cd1-da68-4c34-8f09-62c2cde19e1f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Belladonna and OpiumATROPA BELLADONNA AND OPIUMBryant Ranch Prepack088b9cd1-da68-4c34-8f09-62c2cde19e1f2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 63629-8436

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312104belladonna 16.2 MG / opium 30 MG Rectal SuppositoryPSN088b9cd1-da68-4c34-8f09-62c2cde19e1f102
312104belladonna alkaloids 16.2 MG / opium 30 MG Rectal SuppositorySCD088b9cd1-da68-4c34-8f09-62c2cde19e1f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8436-1636298436014 PACKET in 1 BOX (63629-8436-1) / 1 SUPPOSITORY in 1 PACKET4 packet2021-06-010000-00-00NoNoCurrent