minocycline hydrochloride

Product NDC
70771-1158
11-digit product format
707711158
Labeler code
70771
Product ID
70771-1158_5f19958c-a2d2-4ef1-accd-17186e623625
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minocycline hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203553
Marketing category
ANDA
Marketing start
2025-06-12
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
115 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0020414E5UMINOCYCLINE HYDROCHLORIDE13614-98-7MINOCYCLINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1158-0707711158001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-0) 2025-06-12NoNoHistorical
70771-1158-170771115801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-1) 2025-06-12NoNoHistorical
70771-1158-37077111580330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-3) 2025-06-12NoNoHistorical
70771-1158-570771115805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-5) 2025-06-12NoNoHistorical
70771-1158-77077111580710 BLISTER PACK in 1 CARTON (70771-1158-7) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2025-06-12NoNoHistorical
70771-1158-97077111580990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1158-9) 2025-06-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
minocycline hydrochlorideZydus Lifesciences Limited2025-06-05HUMAN PRESCRIPTION DRUG LABEL4