PROMETHAZINE HYDROCHLORIDE

Product NDC
61919-191
11-digit product format
619190191
Labeler code
61919
Product ID
61919-191_b8554ec3-0b02-4534-e053-2a95a90ac152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA083426
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-191-60PROMETHAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-191-10EA - Each61919-191d40992a0-9645-481d-8547-dad46c1b1c4212019-09-05
61919-191-12EA - Each61919-19109d20a76-253d-4ef9-9b25-8bf2df564bfb12019-08-06
61919-191-30EA - Each61919-191662cd921-f1f3-4e5d-a398-e232b45f867d12015-03-03
61919-191-60EA - Each61919-1919bf3f3cb-bd68-472c-a5f2-16d245aeebc012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-191PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT_RX]4Legacy NDC, 1 package rows20230413_8e0b2adf-12b3-eb4b-e053-2a95a90a41c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN8e0b2adf-12b3-eb4b-e053-2a95a90a41c64
992447promethazine hydrochloride 25 MG Oral TabletSCD8e0b2adf-12b3-eb4b-e053-2a95a90a41c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-191-106191901911010 TABLET in 1 BOTTLE (61919-191-10) 10 tablet2015-01-010000-00-00NoNoCurrent
61919-191-126191901911212 TABLET in 1 BOTTLE (61919-191-12) 12 tablet2015-01-010000-00-00NoNoCurrent
61919-191-156191901911515 TABLET in 1 BOTTLE (61919-191-15) 15 tablet2015-01-010000-00-00NoNoCurrent
61919-191-306191901913030 TABLET in 1 BOTTLE (61919-191-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-191-606191901916060 TABLET in 1 BOTTLE (61919-191-60) 60 tablet2019-07-190000-00-00NoNoCurrent