FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
68999-774
11-digit product format
689990774
Labeler code
68999
Product ID
68999-774_441fd999-03ba-ed67-e063-6294a90ae229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA040026
Marketing category
ANDA
Marketing start
1998-09-25
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6.25 mg/5mL
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 HYDROCHLORIDE6.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992432

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
68999-774-05PROMETHAZINE HYDROCHLORIDE5 mL in 1 CUPSOLUTION51
68999-774-10PROMETHAZINE HYDROCHLORIDE10 mL in 1 CUPSOLUTION101
68999-774-23PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION101
68999-774-23PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION21
68999-774-24PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION21
68999-774-24PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNe5d2156d-1f66-4fdf-a3ae-5e1325218c8b1
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDe5d2156d-1f66-4fdf-a3ae-5e1325218c8b1
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYe5d2156d-1f66-4fdf-a3ae-5e1325218c8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-774-05689990774055 mL in 1 CUP5 mlHistorical
68999-774-106899907741010 mL in 1 CUP10 mlHistorical
68999-774-23689990774232 TRAY in 1 BOX (68999-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-774-10) 2 tray2025-11-20NoNoHistorical
68999-774-24689990774242 TRAY in 1 BOX (68999-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-774-05) 2 tray2025-11-20NoNoHistorical