Minocycline Hydrochloride

Product NDC
50090-2971
11-digit product format
500902971
Labeler code
50090
Product ID
50090-2971_b8c0308f-e3af-4ba3-96b9-a43695b9a408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197984, 197985

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
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
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
50090-2971-0Minocycline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6018
50090-2971-3Minocycline Hydrochloride90 in 1 BOTTLECAPSULE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2971-0EA - Each50090-2971519c907f-3599-4872-b7f0-5d09dac6e8dd12019-05-02
50090-2971-3EA - Each50090-2971c33d144b-ac68-4c9f-a64d-284c08363e3112026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197985minocycline HCl 50 MG Oral CapsulePSNc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197984minocycline 100 MG Oral CapsuleSCDc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197985minocycline 50 MG Oral CapsuleSCDc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2971-05009029710060 CAPSULE in 1 BOTTLE, PLASTIC (50090-2971-0) 60 capsule2015-04-020000-00-00NoNoCurrent
50090-2971-35009029710390 CAPSULE in 1 BOTTLE (50090-2971-3) 90 capsule2017-04-120000-00-00NoNoCurrent