FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
70518-1336
11-digit product format
705181336
Labeler code
70518
Product ID
70518-1336_48d74037-829a-f6bc-e063-6294a90a7d50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065470
Marketing category
ANDA
Marketing start
2018-08-01
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197984

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92Product name220230322
472a6924-c7ed-850b-32ce-a510e887fbf9Product name420230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55dProduct name120201103
7a57513a-a145-4b95-9165-1e0ef21d6017Product name120200326
70555e58-6951-4421-9354-f80c6ce0d92cProduct name720200204
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1336-0Minocycline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3016
70518-1336-1Minocycline Hydrochloride30 in 1 BLISTER PACKCAPSULE3016
70518-1336-2Minocycline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6016
70518-1336-3Minocycline Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE2816

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1336MINOCYCLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 4 package rows20241023_0becbde8-6ec5-4830-a0d9-cfdb7b15eb84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN0becbde8-6ec5-4830-a0d9-cfdb7b15eb8416
197984minocycline 100 MG Oral CapsuleSCD0becbde8-6ec5-4830-a0d9-cfdb7b15eb8416
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY0becbde8-6ec5-4830-a0d9-cfdb7b15eb8416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1336-07051813360030 CAPSULE in 1 BOTTLE, PLASTIC (70518-1336-0) 30 capsule2018-08-010000-00-00NoNoCurrent
70518-1336-17051813360130 CAPSULE in 1 BLISTER PACK (70518-1336-1) 30 capsule2018-08-210000-00-00NoNoCurrent
70518-1336-27051813360260 in 1 BOTTLE, PLASTICHistorical
70518-1336-37051813360328 in 1 BOTTLE, PLASTICHistorical