Promethazine Hydrochloride

Product NDC
68071-4514
11-digit product format
680714514
Labeler code
68071
Product ID
68071-4514_bb8b1b31-b8a0-484c-e053-2a95a90ac9b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA083426
Marketing category
ANDA
Marketing start
1973-09-19
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4514-16807145140110 TABLET in 1 BOTTLE (68071-4514-1) 10 tablet2018-08-020000-00-00NoNoCurrent
68071-4514-4680714514044 TABLET in 1 BOTTLE (68071-4514-4) 4 tablet2018-08-020000-00-00NoNoCurrent
68071-4514-6680714514066 TABLET in 1 BOTTLE (68071-4514-6) 6 tablet2018-08-020000-00-00NoNoCurrent