promethazine hydrochloride

Product NDC
63187-038
11-digit product format
631870038
Labeler code
63187
Product ID
63187-038_52266eb3-3fb1-4838-b2e1-bbe553ff7cf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040863
Marketing category
ANDA
Marketing start
2009-01-27
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-038-10EA - Each63187-03887b00f84-cb76-49c5-8b4f-f73030cdb81212015-12-02
63187-038-30EA - Each63187-0387571469b-f3d0-44da-9d52-179e44ae765512016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-038PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]8Legacy NDC20191121_9910dd1f-297f-48e6-9a0a-30cd978bb90d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-038-106318700381010 TABLET in 1 BOTTLE (63187-038-10) 10 tablet2018-11-010000-00-00NoNoCurrent
63187-038-126318700381212 TABLET in 1 BOTTLE (63187-038-12) 12 tablet2018-11-010000-00-00NoNoCurrent
63187-038-156318700381515 TABLET in 1 BOTTLE (63187-038-15) 15 tablet2018-11-010000-00-00NoNoCurrent
63187-038-206318700382020 TABLET in 1 BOTTLE (63187-038-20) 20 tablet2018-11-010000-00-00NoNoCurrent
63187-038-306318700383030 TABLET in 1 BOTTLE (63187-038-30) 30 tablet2018-11-010000-00-00NoNoCurrent
63187-038-606318700386060 TABLET in 1 BOTTLE (63187-038-60) 60 tablet2018-11-010000-00-00NoNoCurrent
63187-038-906318700389090 TABLET in 1 BOTTLE (63187-038-90) 90 tablet2018-11-010000-00-00NoNoCurrent