TEMAZEPAM

Product NDC
70518-3057
11-digit product format
705183057
Labeler code
70518
Product ID
70518-3057_be5e01ba-6118-26b5-e053-2995a90ab109
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA018163
Marketing category
NDA
Marketing start
2021-03-24
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
8 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
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
70518-3057-02023-03-16C16284748780-1f386c649-c1fc-0266-e053-dadaa90a7c1a3cded012-539f-4c82-b577-50d35a48b496
70518-3057-02023-01-30C16284748780-1f386c649-c1fc-0266-e053-dadaa90a7c1a3cded012-539f-4c82-b577-50d35a48b496

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3057-070518305700100 POUCH in 1 BOX (70518-3057-0) > 1 CAPSULE in 1 POUCH (70518-3057-1) 100 pouch2021-03-240000-00-00NoNoCurrent