FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
61919-047
11-digit product format
619190047
Labeler code
61919
Product ID
61919-047_d61a7bdf-f608-9f99-e053-2995a90ac660
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA091179
Marketing category
ANDA
Marketing start
2019-08-19
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-047-302025-01-30C16284748780-19d75b9d0-621d-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE
61919-047-402021-01-29C16284748780-1ba0f9c33-59b5-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE
61919-047-102020-12-14C16284748780-19d75b9d0-6991-f424-e053-dadaa90a57ce675f2ccf-7c8b-0e03-e053-2a91aa0a8f5a
61919-047-302020-12-14C16284748780-19d75b9d0-621d-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE
61919-047-102020-01-31C16284748780-19d75b9d0-6991-f424-e053-dadaa90a57ce675f2ccf-7c8b-0e03-e053-2a91aa0a8f5a
61919-047-302020-01-31C16284748780-19d75b9d0-621d-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-047-30PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET305
61919-047-40PROMETHAZINE HYDROCHLORIDE40 in 1 BOTTLETABLET401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-047-10EA - Each61919-047024a39c2-568e-4620-af54-e021f2f5f17a12018-04-19
61919-047-12EA - Each61919-04761e040c4-85d2-4776-bb65-3a8418990dc912019-09-05
61919-047-30EA - Each61919-0473d19c422-d1a5-4be8-b14a-58a5d129523f12014-08-01
61919-047-40EA - Each61919-04778fc2d51-dc3d-4c79-9efe-b404b0574f0812019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-047PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]5Legacy NDC, 1 package rows20230331_fcfed7b3-32f8-4fbc-ac41-79d7f45df5fc.zip
61919-047PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190808_8f8b49a5-3ced-10da-e053-2995a90a0fc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSNfcfed7b3-32f8-4fbc-ac41-79d7f45df5fc5
992438promethazine hydrochloride 12.5 MG Oral TabletSCDfcfed7b3-32f8-4fbc-ac41-79d7f45df5fc5
992438promethazine HCl 12.5 MG Oral TabletPSN8f8b49a5-3ced-10da-e053-2995a90a0fc61
992438promethazine hydrochloride 12.5 MG Oral TabletSCD8f8b49a5-3ced-10da-e053-2995a90a0fc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-047-106191900471010 TABLET in 1 BOTTLE (61919-047-10) 10 tablet2018-03-140000-00-00NoNoCurrent
61919-047-126191900471212 TABLET in 1 BOTTLE (61919-047-12) 12 tablet2019-08-190000-00-00NoNoCurrent
61919-047-306191900473030 TABLET in 1 BOTTLE (61919-047-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-047-406191900474040 in 1 BOTTLEHistorical