FDA.reportPublic FDA data

promethazine hydrochloride

Product NDC
17856-0059
11-digit product format
178560059
Labeler code
17856
Product ID
17856-0059_45b43457-b9cd-09a2-e063-6294a90a698d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP
Application
ANDA091675
Marketing category
ANDA
Marketing start
2012-06-08
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0059-12025-03-28C16284748780-12cef2736-b2d5-d83d-e063-dadaa90ab31fPromethazine HCL Syrup
17856-0059-12025-01-30C16284748780-12cef2736-b2d5-d83d-e063-dadaa90ab31fPromethazine HCL Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0059-1promethazine hydrochloride72 in 1 BOX, UNIT-DOSESYRUP724
17856-0059-1promethazine hydrochloride5 mL in 1 CUP, UNIT-DOSESYRUP54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0059PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP]3Current NDC, 2 package rows20250525_69934bbb-922c-4752-b253-f2f07340de8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN69934bbb-922c-4752-b253-f2f07340de8d4
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD69934bbb-922c-4752-b253-f2f07340de8d4
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSY69934bbb-922c-4752-b253-f2f07340de8d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-0059-11785600590172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1) / 5 mL in 1 CUP, UNIT-DOSE2023-11-13NoNoCurrent