FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
51655-085
11-digit product format
516550085
Labeler code
51655
Product ID
51655-085_46ddd736-abb2-356b-e063-6394a90a9e76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091179
Marketing category
ANDA
Marketing start
2014-06-01
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992447

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-085-532023-02-15C16284748780-19d75b9d0-1bb2-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only
51655-085-532020-01-31C16284748780-19d75b9d0-1bb2-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-085-20Promethazine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET203
51655-085-53Promethazine Hydrochloride10 in 1 BOTTLE, DISPENSINGTABLET103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-085PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20230216_ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNba4ec2d8-1da4-473b-9ef8-57051cb2c0f73
992447promethazine hydrochloride 25 MG Oral TabletSCDba4ec2d8-1da4-473b-9ef8-57051cb2c0f73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-085-205165500852020 TABLET in 1 BOTTLE, PLASTIC (51655-085-20) 20 tablet2022-10-14NoNoCurrent
51655-085-535165500855310 TABLET in 1 BOTTLE, DISPENSING (51655-085-53) 10 tablet2014-06-01NoNoCurrent