FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
71205-126
11-digit product format
712050126
Labeler code
71205
Product ID
71205-126_fe741fc7-f692-49a0-bf51-04c6a3b2e1bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-126-10PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET105
71205-126-12PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLETABLET125
71205-126-15PROMETHAZINE HYDROCHLORIDE15 in 1 BOTTLETABLET155
71205-126-20PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLETABLET205
71205-126-30PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-126-10EA - Each71205-126330fbe77-d7fb-49bc-b244-833512a3d43012019-06-19
71205-126-12EA - Each71205-1263ba248eb-9ba6-4df2-969e-2af5948fa56812019-06-19
71205-126-15EA - Each71205-1269576c266-bdbd-4e69-90a0-29174944feb912020-01-03
71205-126-20EA - Each71205-126ded0c4c8-d2b2-4bcc-8b3d-2fe31a29552a12019-10-07
71205-126-30EA - Each71205-1267634f2f2-7123-4f9c-9210-c6fc7fe7e5bc12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-126PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 5 package rows20220421_29a8b172-1bad-40db-8d73-1fe7fb309cff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN29a8b172-1bad-40db-8d73-1fe7fb309cff5
992447promethazine hydrochloride 25 MG Oral TabletSCD29a8b172-1bad-40db-8d73-1fe7fb309cff5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-126-107120501261010 TABLET in 1 BOTTLE (71205-126-10) 10 tablet2018-10-010000-00-00NoNoCurrent
71205-126-127120501261212 TABLET in 1 BOTTLE (71205-126-12) 12 tablet2018-10-010000-00-00NoNoCurrent
71205-126-157120501261515 TABLET in 1 BOTTLE (71205-126-15) 15 tablet2018-10-010000-00-00NoNoCurrent
71205-126-207120501262020 TABLET in 1 BOTTLE (71205-126-20) 20 tablet2018-10-010000-00-00NoNoCurrent
71205-126-307120501263030 TABLET in 1 BOTTLE (71205-126-30) 30 tablet2018-10-010000-00-00NoNoCurrent