FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
71205-658
11-digit product format
712050658
Labeler code
71205
Product ID
71205-658_f274f5be-72ff-42e5-a4ba-8d1d957375b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040596
Marketing category
ANDA
Marketing start
2014-01-13
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
71205-658-10Promethazine Hydrochloride10 in 1 BOTTLETABLET103
71205-658-12Promethazine Hydrochloride12 in 1 BOTTLETABLET123
71205-658-20Promethazine Hydrochloride20 in 1 BOTTLETABLET203
71205-658-30Promethazine Hydrochloride30 in 1 BOTTLETABLET303
71205-658-60Promethazine Hydrochloride60 in 1 BOTTLETABLET603
71205-658-90Promethazine Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-658-10EA - Each71205-6585c9f8061-88ec-4b27-85bd-6cb65b8d03f112022-08-04
71205-658-12EA - Each71205-6587c533220-f55d-40a9-aadd-846f4f6cf8db12023-06-06
71205-658-20EA - Each71205-658c1f620a2-ae9e-4636-84cf-27ceb786a6cb12022-12-07
71205-658-30EA - Each71205-658f4d60e1d-1547-4dec-a812-17901e3419cd12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-658PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20230115_59b906c6-2ccc-416e-b3ee-db09bf553146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN59b906c6-2ccc-416e-b3ee-db09bf5531463
992447promethazine hydrochloride 25 MG Oral TabletSCD59b906c6-2ccc-416e-b3ee-db09bf5531463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-658-107120506581010 TABLET in 1 BOTTLE (71205-658-10) 10 tablet2022-05-050000-00-00NoNoCurrent
71205-658-127120506581212 TABLET in 1 BOTTLE (71205-658-12) 12 tablet2023-01-04NoNoCurrent
71205-658-207120506582020 TABLET in 1 BOTTLE (71205-658-20) 20 tablet2022-09-270000-00-00NoNoCurrent
71205-658-307120506583030 TABLET in 1 BOTTLE (71205-658-30) 30 tablet2022-05-050000-00-00NoNoCurrent
71205-658-607120506586060 TABLET in 1 BOTTLE (71205-658-60) 60 tablet2022-05-050000-00-00NoNoCurrent
71205-658-907120506589090 TABLET in 1 BOTTLE (71205-658-90) 90 tablet2022-05-050000-00-00NoNoCurrent