FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
71335-0989
11-digit product format
713350989
Labeler code
71335
Product ID
71335-0989_e2c0c4b9-d14f-4b7b-a98c-b3a7f78ec8d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040712
Marketing category
ANDA
Marketing start
2007-05-04
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
12.5 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992438

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
71335-0989-0PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET307
71335-0989-1PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLETABLET127
71335-0989-2PROMETHAZINE HYDROCHLORIDE4 in 1 BOTTLETABLET47
71335-0989-3PROMETHAZINE HYDROCHLORIDE2 in 1 BOTTLETABLET27
71335-0989-5PROMETHAZINE HYDROCHLORIDE6 in 1 BOTTLETABLET67
71335-0989-6PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET107
71335-0989-7PROMETHAZINE HYDROCHLORIDE40 in 1 BOTTLETABLET407
71335-0989-8PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLETABLET207
71335-0989-9PROMETHAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0989-0EA - Each71335-0989037022c0-392a-4d6a-af3e-e349a9a274c912022-01-06
71335-0989-9EA - Each71335-098913abcc34-0799-48e1-a4b7-ccf1b3e15caa12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0989PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 9 package rows20240724_f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSNf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c477
992438promethazine hydrochloride 12.5 MG Oral TabletSCDf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0989-07133509890030 TABLET in 1 BOTTLE (71335-0989-0) 30 tablet2019-01-030000-00-00NoNoCurrent
71335-0989-17133509890112 TABLET in 1 BOTTLE (71335-0989-1) 12 tablet2024-07-090000-00-00NoNoCurrent
71335-0989-2713350989024 TABLET in 1 BOTTLE (71335-0989-2) 4 tablet2024-07-090000-00-00NoNoCurrent
71335-0989-3713350989032 TABLET in 1 BOTTLE (71335-0989-3) 2 tablet2024-07-090000-00-00NoNoCurrent
71335-0989-5713350989056 TABLET in 1 BOTTLE (71335-0989-5) 6 tablet2024-07-090000-00-00NoNoCurrent
71335-0989-67133509890610 TABLET in 1 BOTTLE (71335-0989-6) 10 tablet2021-12-010000-00-00NoNoCurrent
71335-0989-77133509890740 TABLET in 1 BOTTLE (71335-0989-7) 40 tablet2024-07-090000-00-00NoNoCurrent
71335-0989-87133509890820 TABLET in 1 BOTTLE (71335-0989-8) 20 tablet2024-07-090000-00-00NoNoCurrent
71335-0989-97133509890960 TABLET in 1 BOTTLE (71335-0989-9) 60 tablet2018-10-300000-00-00NoNoCurrent