FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
12634-418
11-digit product format
126340418
Labeler code
12634
Product ID
12634-418_ca133ae3-6acb-4d3e-82e0-4946943b7440
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca, Inc
Application
ANDA091179
Marketing category
ANDA
Marketing start
1999-06-10
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
2019-12-31
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
12634-418-002020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-012020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-402020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-522020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-602020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-612020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-652020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-662020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-712020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-742020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-802020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-822020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-852020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-912020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-922020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-942020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-952020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-962020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet
12634-418-992020-01-31C16284748780-19d75b9d0-0d78-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-418-00Promethazine Hydrochloride10 in 1 BOTTLETABLET101
12634-418-01Promethazine Hydrochloride100 in 1 BOTTLETABLET1001
12634-418-40Promethazine Hydrochloride40 in 1 BOTTLETABLET401
12634-418-52Promethazine Hydrochloride12 in 1 BLISTER PACKTABLET121
12634-418-60Promethazine Hydrochloride60 in 1 BOTTLETABLET601
12634-418-61Promethazine Hydrochloride10 in 1 BLISTER PACKTABLET101
12634-418-65Promethazine Hydrochloride5 in 1 BLISTER PACKTABLET51
12634-418-66Promethazine Hydrochloride6 in 1 BLISTER PACKTABLET61
12634-418-71Promethazine Hydrochloride30 in 1 BOTTLETABLET301
12634-418-74Promethazine Hydrochloride24 in 1 BOTTLETABLET241
12634-418-80Promethazine Hydrochloride20 in 1 BOTTLETABLET201
12634-418-82Promethazine Hydrochloride12 in 1 BOTTLETABLET121
12634-418-85Promethazine Hydrochloride15 in 1 BOTTLETABLET151
12634-418-91Promethazine Hydrochloride1 in 1 BLISTER PACKTABLET11
12634-418-92Promethazine Hydrochloride2 in 1 BOTTLETABLET21
12634-418-94Promethazine Hydrochloride4 in 1 BOTTLETABLET41
12634-418-95Promethazine Hydrochloride5 in 1 BOTTLETABLET51
12634-418-96Promethazine Hydrochloride6 in 1 BOTTLETABLET61
12634-418-99Promethazine Hydrochloride9 in 1 BOTTLETABLET91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-418-71EA - Each12634-418cade45bf-067e-43dc-ac77-17fb3ed4059212015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-418PROMETHAZINE HYDROCHLORIDE TABLET [APOTHECA, INC]1Legacy NDC, 19 package rows20141023_89d648db-dadc-436d-8a4d-d1637ea0e6a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN89d648db-dadc-436d-8a4d-d1637ea0e6a51
992447promethazine hydrochloride 25 MG Oral TabletSCD89d648db-dadc-436d-8a4d-d1637ea0e6a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-418-001263404180010 in 1 BOTTLEHistorical
12634-418-0112634041801100 in 1 BOTTLEHistorical
12634-418-401263404184040 in 1 BOTTLEHistorical
12634-418-521263404185212 in 1 BLISTER PACKHistorical
12634-418-601263404186060 in 1 BOTTLEHistorical
12634-418-611263404186110 in 1 BLISTER PACKHistorical
12634-418-65126340418655 in 1 BLISTER PACKHistorical
12634-418-66126340418666 in 1 BLISTER PACKHistorical
12634-418-711263404187130 in 1 BOTTLEHistorical
12634-418-741263404187424 in 1 BOTTLEHistorical
12634-418-801263404188020 in 1 BOTTLEHistorical
12634-418-821263404188212 in 1 BOTTLEHistorical
12634-418-851263404188515 in 1 BOTTLEHistorical
12634-418-91126340418911 in 1 BLISTER PACKHistorical
12634-418-92126340418922 in 1 BOTTLEHistorical
12634-418-94126340418944 in 1 BOTTLEHistorical
12634-418-95126340418955 in 1 BOTTLEHistorical
12634-418-96126340418966 in 1 BOTTLEHistorical
12634-418-99126340418999 in 1 BOTTLEHistorical