FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
71335-1139
11-digit product format
713351139
Labeler code
71335
Product ID
71335-1139_b02527e6-b912-4a80-8d6a-a78a7685dc55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
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
71335-1139-0Promethazine Hydrochloride14 in 1 BOTTLETABLET147
71335-1139-1Promethazine Hydrochloride15 in 1 BOTTLETABLET157
71335-1139-2Promethazine Hydrochloride30 in 1 BOTTLETABLET307
71335-1139-3Promethazine Hydrochloride10 in 1 BOTTLETABLET107
71335-1139-4Promethazine Hydrochloride20 in 1 BOTTLETABLET207
71335-1139-5Promethazine Hydrochloride12 in 1 BOTTLETABLET127
71335-1139-6Promethazine Hydrochloride60 in 1 BOTTLETABLET607
71335-1139-7Promethazine Hydrochloride90 in 1 BOTTLETABLET907
71335-1139-8Promethazine Hydrochloride6 in 1 BOTTLETABLET67
71335-1139-9Promethazine Hydrochloride56 in 1 BOTTLETABLET567

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1139-2EA - Each71335-113923488318-1186-4ae6-ae01-a2951034804412020-02-13
71335-1139-6EA - Each71335-1139690e9c25-f4a7-4df3-8b6d-65f0e9e98e9112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1139PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240809_ea490539-007b-47b1-bef9-22de02ae7c64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNea490539-007b-47b1-bef9-22de02ae7c647
992447promethazine hydrochloride 25 MG Oral TabletSCDea490539-007b-47b1-bef9-22de02ae7c647

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1139-07133511390014 TABLET in 1 BOTTLE (71335-1139-0) 14 tablet2024-04-030000-00-00NoNoCurrent
71335-1139-17133511390115 TABLET in 1 BOTTLE (71335-1139-1) 15 tablet2019-11-010000-00-00NoNoCurrent
71335-1139-27133511390230 TABLET in 1 BOTTLE (71335-1139-2) 30 tablet2019-03-060000-00-00NoNoCurrent
71335-1139-37133511390310 TABLET in 1 BOTTLE (71335-1139-3) 10 tablet2019-03-140000-00-00NoNoCurrent
71335-1139-47133511390420 TABLET in 1 BOTTLE (71335-1139-4) 20 tablet2019-03-190000-00-00NoNoCurrent
71335-1139-57133511390512 TABLET in 1 BOTTLE (71335-1139-5) 12 tablet2019-03-260000-00-00NoNoCurrent
71335-1139-67133511390660 TABLET in 1 BOTTLE (71335-1139-6) 60 tablet2019-04-120000-00-00NoNoCurrent
71335-1139-77133511390790 TABLET in 1 BOTTLE (71335-1139-7) 90 tablet2019-06-030000-00-00NoNoCurrent
71335-1139-8713351139086 TABLET in 1 BOTTLE (71335-1139-8) 6 tablet2019-10-040000-00-00NoNoCurrent
71335-1139-97133511390956 TABLET in 1 BOTTLE (71335-1139-9) 56 tablet2019-04-170000-00-00NoNoCurrent