FDA.reportPublic FDA data

Belladonna and Opium

Product NDC
0574-7040
11-digit product format
005747040
Labeler code
0574
Product ID
0574-7040_7b45a1d7-c3a5-4434-a848-45638cedd6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPA BELLADONNA and OPIUM
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis US LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1997-04-22
Substance
ATROPA BELLADONNA; OPIUM
Active strength
16.2; 60 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
OPIUM60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii37M3MZ001L, WQZ3G9PF0H
Rxcui312104, 312107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-7040-04Belladonna and Opium1 in 1 PACKETSUPPOSITORY110
0574-7040-04Belladonna and Opium4 in 1 BOXSUPPOSITORY410
0574-7040-12Belladonna and Opium1 in 1 PACKETSUPPOSITORY110
0574-7040-12Belladonna and Opium12 in 1 BOXSUPPOSITORY1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7040-04EA - Each0574-7040ab159889-0ebe-4ca8-b2de-4a619efaf0eb12019-04-11
0574-7040-12EA - Each0574-704025733d35-3a15-4c1c-a099-cbb4294077f512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
OPIUMACTIVE INGREDIENT37M3MZ001LBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
OPIUMACTIVE MOIETY37M3MZ001LBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4BELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7040BELLADONNA AND OPIUM (ATROPA BELLADONNA AND OPIUM) SUPPOSITORY [PADAGIS US LLC]10Current NDC, Legacy NDC, 4 package rows20240426_8301e76b-134a-43d2-a7dc-c600ccf2695c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312104belladonna 16.2 MG / opium 30 MG Rectal SuppositoryPSN8301e76b-134a-43d2-a7dc-c600ccf2695c10
312107belladonna 16.2 MG / opium 60 MG Rectal SuppositoryPSN8301e76b-134a-43d2-a7dc-c600ccf2695c10
312104belladonna alkaloids 16.2 MG / opium 30 MG Rectal SuppositorySCD8301e76b-134a-43d2-a7dc-c600ccf2695c10
312107belladonna alkaloids 16.2 MG / opium 60 MG Rectal SuppositorySCD8301e76b-134a-43d2-a7dc-c600ccf2695c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-7040-04005747040044 PACKET in 1 BOX (0574-7040-04) / 1 SUPPOSITORY in 1 PACKET4 packet2018-08-220000-00-00NoNoCurrent
0574-7040-120057470401212 PACKET in 1 BOX (0574-7040-12) / 1 SUPPOSITORY in 1 PACKET12 packet1997-04-220000-00-00NoNoCurrent