FDA.reportPublic FDA data

Sucraid

Product NDC
67871-111
11-digit product format
678710111
Labeler code
67871
Product ID
67871-111_4719ec33-5660-444a-e063-6294a90ab40c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sacrosidase
Dosage form
SOLUTION
Route
ORAL
Labeler
QOL Medical, LLC
Application
BLA020772
Marketing category
BLA
Marketing start
1998-04-09
Substance
SACROSIDASE
Active strength
8500 [iU]/mL
Pharmacologic classes
Sucrose-specific Enzyme [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sucraid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SACROSIDASE8500 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8A7F670F2Y
Rxcui213337, 312872

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58d0d555-4147-0be4-d892-798a99a4fd4aProduct name220200325

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67871-111-042021-08-25C16284748780-19d75b9d0-63b2-f424-e053-dadaa90a57ceSucraid ® (sacrosidase) Oral Solution:
67871-111-042021-07-23C16284748780-19d75b9d0-63b2-f424-e053-dadaa90a57ceSucraid ® (sacrosidase) Oral Solution:
67871-111-042020-04-15C16284748780-19d75b9d0-63b2-f424-e053-dadaa90a57ceSucraid ® (sacrosidase) Oral Solution:
67871-111-042020-01-31C16284748780-19d75b9d0-63b2-f424-e053-dadaa90a57ceSucraid ® (sacrosidase) Oral Solution:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67871-111-01Sucraid118 mL in 1 BOTTLESOLUTION11821
67871-111-04Sucraid2 in 1 CARTONSOLUTION221
67871-111-05Sucraid5 in 1 POUCHSOLUTION521
67871-111-05Sucraid2 mL in 1 VIAL, SINGLE-USESOLUTION221
67871-111-06Sucraid25 in 1 BOXSOLUTION2521
67871-111-07Sucraid6 in 1 CARTONSOLUTION621

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67871-111-01ML - Milliliter67871-111b4336da3-13a8-4424-b8b1-057e20ec840812020-05-08
67871-111-04ML - Milliliter67871-1117665711c-05f9-4f22-a652-4e06fbbe70cd12012-07-24
67871-111-05ML - Milliliter67871-111b0548945-1460-4e81-9e21-4c29752270ec12022-07-06
67871-111-06ML - Milliliter67871-111f715bd5a-184c-4557-a35b-4b6740e8c19812022-07-06
67871-111-07ML - Milliliter67871-1112bbc5068-3d00-4eec-8762-d446d6a1c43812022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sacrosidaseACTIVE INGREDIENT8A7F670F2YSUCRAID (SACROSIDASE) SOLUTION [QOL MEDICAL, LLC]8
sacrosidaseACTIVE MOIETY8A7F670F2YSUCRAID (SACROSIDASE) SOLUTION [QOL MEDICAL, LLC]8
glycerinINACTIVE INGREDIENTPDC6A3C0OXSUCRAID (SACROSIDASE) SOLUTION [QOL MEDICAL, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67871-111SUCRAID (SACROSIDASE) SOLUTION [QOL MEDICAL, LLC]18Current NDC, Legacy NDC, 6 package rows20240816_d613bb7f-c3f4-462e-81a2-da2347cc4b6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312872sacrosidase 8500 UNT in 1 mL Oral SolutionPSNd613bb7f-c3f4-462e-81a2-da2347cc4b6b21
213337Sucraid 8500 UNT in 1 mL Oral SolutionPSNd613bb7f-c3f4-462e-81a2-da2347cc4b6b21
213337sacrosidase 8500 UNT/ML Oral Solution [Sucraid]SBDd613bb7f-c3f4-462e-81a2-da2347cc4b6b21
312872sacrosidase 8500 UNT/ML Oral SolutionSCDd613bb7f-c3f4-462e-81a2-da2347cc4b6b21
312872sacrosidase 8500 UNT per 1 ML Oral SolutionSYd613bb7f-c3f4-462e-81a2-da2347cc4b6b21
213337Sucraid 8500 UNT per 1 ML Oral SolutionSYd613bb7f-c3f4-462e-81a2-da2347cc4b6b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67871-111-0167871011101118 mL in 1 BOTTLE118 mlHistorical
67871-111-04678710111042 BOTTLE in 1 CARTON (67871-111-04) / 118 mL in 1 BOTTLE (67871-111-01) 2 bottle1998-04-090000-00-00NoNoCurrent
67871-111-05678710111055 in 1 POUCHHistorical
67871-111-066787101110625 in 1 BOXHistorical
67871-111-07678710111076 BOX in 1 CARTON (67871-111-07) / 25 POUCH in 1 BOX (67871-111-06) / 5 VIAL, SINGLE-USE in 1 POUCH (67871-111-05) / 2 mL in 1 VIAL, SINGLE-USE6 box2022-05-250000-00-00NoNoCurrent