Promethazine Hydrochloride

Product NDC
63739-213
11-digit product format
637390213
Labeler code
63739
Product ID
63739-213_c05609d7-c899-1b0e-e053-2a95a90a999b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA084176
Marketing category
ANDA
Marketing start
1975-12-19
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-213-102020-07-22C16284748780-1ab0e2407-3058-f274-e053-dbdaa90a6471818a4d9a-c8a2-476c-b70c-0840b6d603a1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-213-10EA - Each63739-21389affebc-8b30-4931-8c7f-2fc0859a310b12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-213-106373902131010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-213-10) > 10 TABLET in 1 BLISTER PACK10 blister pack1975-12-190000-00-00NoNoCurrent