Promethazine Hydrochloride

Product NDC
70518-2896
11-digit product format
705182896
Labeler code
70518
Product ID
70518-2896_d787475a-659f-7969-e053-2a95a90aeba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA083312
Marketing category
ANDA
Marketing start
2020-09-25
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2896-02022-02-08C16284748780-1d6a99b39-6253-a426-e053-dadaa90af4c2c5201df2-87f2-475d-89d5-b0687269475d
70518-2896-02022-01-28C16284748780-1d6a99b39-6253-a426-e053-dadaa90af4c2c5201df2-87f2-475d-89d5-b0687269475d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2896-07051828960025 VIAL, SINGLE-DOSE in 1 PACKAGE (70518-2896-0) > 1 mL in 1 VIAL, SINGLE-DOSE (70518-2896-1) 2020-09-250000-00-00NoNoCurrent