FDA.reportPublic FDA data

promethazine hydrochloride

Product NDC
27808-051
11-digit product format
278080051
Labeler code
27808
Product ID
27808-051_f00d9daa-3d9f-4645-b4a2-ecef6f85bab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA091675
Marketing category
ANDA
Marketing start
2012-06-08
Marketing end
2027-03-01
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6.25 mg/5mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
promethazine hydrochloride

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
27808-051-012021-10-21C16284748780-19d75b9d0-b14f-f424-e053-dadaa90a57cePromethazine HCL Syrup
27808-051-012020-01-31C16284748780-19d75b9d0-b14f-f424-e053-dadaa90a57cePromethazine HCL Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-051-01promethazine hydrochloride237 mL in 1 BOTTLESYRUP2377
27808-051-02promethazine hydrochloride473 mL in 1 BOTTLESYRUP4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-051-02ML - Milliliter27808-05138a3d390-8ecb-4af1-97db-13ef59ebd69e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-051PROMETHAZINE HYDROCHLORIDE SYRUP [CRANBURY PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20250131_d32ea9db-11d4-400d-b7ef-dd0ec01b796d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNd32ea9db-11d4-400d-b7ef-dd0ec01b796d7
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDd32ea9db-11d4-400d-b7ef-dd0ec01b796d7
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYd32ea9db-11d4-400d-b7ef-dd0ec01b796d7
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
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNc0a68671-407b-4840-9662-04f168cff1cb2
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDc0a68671-407b-4840-9662-04f168cff1cb2
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYc0a68671-407b-4840-9662-04f168cff1cb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-051-0127808005101237 mL in 1 BOTTLE (27808-051-01) 237 ml2021-09-300000-00-00NoNoCurrent
27808-051-0227808005102473 mL in 1 BOTTLE (27808-051-02) 473 ml2021-09-302027-03-01NoNoCurrent