PROMETHAZINE HYDROCHLORIDE

Product NDC
71335-1359
11-digit product format
713351359
Labeler code
71335
Product ID
71335-1359_429073f4-8be1-4b1c-8f2d-35db4c21956c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1359-0PROMETHAZINE HYDROCHLORIDE14 in 1 BOTTLETABLET14103
71335-1359-1PROMETHAZINE HYDROCHLORIDE15 in 1 BOTTLETABLET15103
71335-1359-2PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET30103
71335-1359-3PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET10103
71335-1359-4PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLETABLET20103
71335-1359-5PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLETABLET12103
71335-1359-6PROMETHAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET60103
71335-1359-7PROMETHAZINE HYDROCHLORIDE90 in 1 BOTTLETABLET90103
71335-1359-8PROMETHAZINE HYDROCHLORIDE6 in 1 BOTTLETABLET6103
71335-1359-9PROMETHAZINE HYDROCHLORIDE56 in 1 BOTTLETABLET56103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1359-7EA - Each71335-1359e59cfb18-3fd2-44a0-a325-b960d59d5ed812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1359PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240725_e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNe6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488103
992447promethazine hydrochloride 25 MG Oral TabletSCDe6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1359-07133513590014 TABLET in 1 BOTTLE (71335-1359-0) 14 tablet2024-07-090000-00-00NoNoCurrent
71335-1359-17133513590115 TABLET in 1 BOTTLE (71335-1359-1) 15 tablet2022-03-160000-00-00NoNoCurrent
71335-1359-27133513590230 TABLET in 1 BOTTLE (71335-1359-2) 30 tablet2019-11-260000-00-00NoNoCurrent
71335-1359-37133513590310 TABLET in 1 BOTTLE (71335-1359-3) 10 tablet2020-07-300000-00-00NoNoCurrent
71335-1359-47133513590420 TABLET in 1 BOTTLE (71335-1359-4) 20 tablet2020-12-020000-00-00NoNoCurrent
71335-1359-57133513590512 TABLET in 1 BOTTLE (71335-1359-5) 12 tablet2020-05-070000-00-00NoNoCurrent
71335-1359-67133513590660 TABLET in 1 BOTTLE (71335-1359-6) 60 tablet2020-05-120000-00-00NoNoCurrent
71335-1359-77133513590790 TABLET in 1 BOTTLE (71335-1359-7) 90 tablet2020-06-040000-00-00NoNoCurrent
71335-1359-8713351359086 TABLET in 1 BOTTLE (71335-1359-8) 6 tablet2020-01-020000-00-00NoNoCurrent
71335-1359-97133513590956 TABLET in 1 BOTTLE (71335-1359-9) 56 tablet2020-09-090000-00-00NoNoCurrent