PROMETHAZINE HYDROCHLORIDE

Product NDC
55700-221
11-digit product format
557000221
Labeler code
55700
Product ID
55700-221_d2e795b9-fdb9-4aef-962e-93c87eec99ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA040712
Marketing category
ANDA
Marketing start
2014-07-09
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-221-05EA - Each55700-2210905797e-2615-4abf-a838-76f961912e5012016-05-16
55700-221-10EA - Each55700-22198dc4bad-4a9f-4fc0-bdc1-89ecf5d1cd4e12016-05-16
55700-221-12EA - Each55700-22189322c3a-ac8d-4952-952d-300d3725fd8912016-05-16
55700-221-15EA - Each55700-22123d6e9ab-182f-4580-bbe0-9d2c2b03c8ec12016-05-16
55700-221-16EA - Each55700-2219ac3ab11-1448-4ae9-8b5e-fedade03bd7512016-05-16
55700-221-20EA - Each55700-221b8b1bcf2-6ec1-4c69-b042-46b90e358cff12016-05-16
55700-221-30EA - Each55700-2214c4699f7-9cbc-4f2c-a154-eb3685ff7ee512016-05-16
55700-221-60EA - Each55700-22193c59129-9f66-4ca8-b7ef-68357a202ca512016-05-16
55700-221-90EA - Each55700-221dcc7311b-e53b-4bce-b538-824ce562d30512016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-221PROMETHAZINE HYDROCHLORIDE TABLET [QUALITY CARE PRODUCTS LLC]11Legacy NDC20250101_004c4371-e4dc-4d79-8b05-aa2efea49043.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-221-05557000221055 TABLET in 1 BOTTLE (55700-221-05) 5 tablet2015-02-180000-00-00NoNoCurrent
55700-221-155570002211515 TABLET in 1 BOTTLE (55700-221-15) 15 tablet2015-02-180000-00-00NoNoCurrent
55700-221-205570002212020 TABLET in 1 BOTTLE (55700-221-20) 20 tablet2015-02-180000-00-00NoNoCurrent
55700-221-305570002213030 TABLET in 1 BOTTLE (55700-221-30) 30 tablet2015-02-180000-00-00NoNoCurrent
55700-221-605570002216060 TABLET in 1 BOTTLE (55700-221-60) 60 tablet2015-02-180000-00-00NoNoCurrent
55700-221-905570002219090 TABLET in 1 BOTTLE (55700-221-90) 90 tablet2015-02-180000-00-00NoNoCurrent