Promethazine Hydrochloride

Product NDC
63187-949
11-digit product format
631870949
Labeler code
63187
Product ID
63187-949_2a9166ed-4d36-4d09-8c83-f0ccd6feeb74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091179
Marketing category
ANDA
Marketing start
2011-03-03
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-949-10Promethazine Hydrochloride10 in 1 BOTTLETABLET101
63187-949-12Promethazine Hydrochloride12 in 1 BOTTLETABLET121
63187-949-15Promethazine Hydrochloride15 in 1 BOTTLETABLET151
63187-949-20Promethazine Hydrochloride20 in 1 BOTTLETABLET201
63187-949-30Promethazine Hydrochloride30 in 1 BOTTLETABLET301
63187-949-60Promethazine Hydrochloride60 in 1 BOTTLETABLET601
63187-949-90Promethazine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-949-10EA - Each63187-94985ed4990-7530-46c7-8d0c-a6991680fed112018-02-20
63187-949-30EA - Each63187-94959195b5f-2d64-4857-8504-bc04e52d0c3612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-949PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Legacy NDC, 7 package rows20180130_2a9166ed-4d36-4d09-8c83-f0ccd6feeb74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN2a9166ed-4d36-4d09-8c83-f0ccd6feeb741
992447promethazine hydrochloride 25 MG Oral TabletSCD2a9166ed-4d36-4d09-8c83-f0ccd6feeb741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63187-949-106318709491010 in 1 BOTTLEHistorical
63187-949-126318709491212 in 1 BOTTLEHistorical
63187-949-156318709491515 in 1 BOTTLEHistorical
63187-949-206318709492020 in 1 BOTTLEHistorical
63187-949-306318709493030 in 1 BOTTLEHistorical
63187-949-606318709496060 in 1 BOTTLEHistorical
63187-949-906318709499090 in 1 BOTTLEHistorical