Devrom

Product NDC
49309-001
11-digit product format
493090001
Labeler code
49309
Product ID
49309-001_61d82c84-289a-4d83-a8ed-6c026f9edec9
Type
HUMAN OTC DRUG
Nonproprietary name
bismuth subgallate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
The Parthenon Co., Inc.
Application
M026
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-01
Substance
BISMUTH SUBGALLATE
Active strength
200 mg/1
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBGALLATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYIW503MI7V
Rxcui308757, 1942846

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49309-001-012024-01-30C16284748780-11030e365-1f05-111a-e063-dadaa90a10e2Devrom ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49309-001-01Devrom100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49309-001-01EA - Each49309-00146d4c17d-f75e-4a26-bc51-d87d4585975912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49309-001DEVROM (BISMUTH SUBGALLATE) TABLET, CHEWABLE [THE PARTHENON CO., INC.]3Current NDC, Legacy NDC, 1 package rows20241122_6a9408b1-9085-42e6-9104-c6986d5446a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308757bismuth subgallate 200 MG Chewable TabletPSN6a9408b1-9085-42e6-9104-c6986d5446a93
1942846Devrom 200 MG Chewable TabletPSN6a9408b1-9085-42e6-9104-c6986d5446a93
1942846bismuth subgallate 200 MG Chewable Tablet [Devrom]SBD6a9408b1-9085-42e6-9104-c6986d5446a93
308757bismuth subgallate 200 MG Chewable TabletSCD6a9408b1-9085-42e6-9104-c6986d5446a93
1942846Devrom 200 MG Chewable TabletSY6a9408b1-9085-42e6-9104-c6986d5446a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49309-001-0149309000101100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (49309-001-01) 2018-12-010000-00-00NoNoCurrent