PROMETHAZINE HYDROCHLORIDE

Product NDC
55700-690
11-digit product format
557000690
Labeler code
55700
Product ID
55700-690_2da3e9b6-5c8d-485e-89c7-51a46a8b9686
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA040712
Marketing category
ANDA
Marketing start
2018-09-28
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
13 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
55700-690-302025-01-09C16284748780-1f386c64a-48d3-0266-e053-dadaa90a7c1a0b7c0ed1-adea-4541-a4e5-bfa3e9d34f47
55700-690-302023-01-30C16284748780-1f386c64a-48d3-0266-e053-dadaa90a7c1a0b7c0ed1-adea-4541-a4e5-bfa3e9d34f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-690-305570006903030 TABLET in 1 BOTTLE (55700-690-30) 30 tablet2018-09-280000-00-00NoNoCurrent