FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
71335-1123
11-digit product format
713351123
Labeler code
71335
Product ID
71335-1123_dc18eddf-e652-4d97-acc0-d6ad545c5ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065470
Marketing category
ANDA
Marketing start
2008-03-11
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
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
71335-1123-0Minocycline Hydrochloride50 in 1 BOTTLECAPSULE506
71335-1123-1Minocycline Hydrochloride20 in 1 BOTTLECAPSULE206
71335-1123-2Minocycline Hydrochloride30 in 1 BOTTLECAPSULE306
71335-1123-3Minocycline Hydrochloride28 in 1 BOTTLECAPSULE286
71335-1123-4Minocycline Hydrochloride60 in 1 BOTTLECAPSULE606
71335-1123-5Minocycline Hydrochloride100 in 1 BOTTLECAPSULE1006
71335-1123-6Minocycline Hydrochloride14 in 1 BOTTLECAPSULE146
71335-1123-7Minocycline Hydrochloride120 in 1 BOTTLECAPSULE1206
71335-1123-8Minocycline Hydrochloride90 in 1 BOTTLECAPSULE906
71335-1123-9Minocycline Hydrochloride15 in 1 BOTTLECAPSULE156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1123-1EA - Each71335-11230a5a18a4-2f25-40b8-9514-e8065e5be1f012019-09-05
71335-1123-2EA - Each71335-1123890b76f2-de42-4b99-a772-81106dabe83712019-09-05
71335-1123-4EA - Each71335-11232035f750-cc52-4c49-8b82-b52f9343bdff12019-09-05
71335-1123-6EA - Each71335-1123f972b19d-ca54-4705-b86e-7b492b851d3612019-09-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNbb3b9a7e-6724-4c2a-b3cb-236f522b31a86
197984minocycline 100 MG Oral CapsuleSCDbb3b9a7e-6724-4c2a-b3cb-236f522b31a86
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYbb3b9a7e-6724-4c2a-b3cb-236f522b31a86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1123-07133511230050 CAPSULE in 1 BOTTLE (71335-1123-0) 50 capsule2022-05-020000-00-00NoNoCurrent
71335-1123-17133511230120 CAPSULE in 1 BOTTLE (71335-1123-1) 20 capsule2019-11-060000-00-00NoNoCurrent
71335-1123-27133511230230 CAPSULE in 1 BOTTLE (71335-1123-2) 30 capsule2019-02-260000-00-00NoNoCurrent
71335-1123-37133511230328 CAPSULE in 1 BOTTLE (71335-1123-3) 28 capsule2022-05-020000-00-00NoNoCurrent
71335-1123-47133511230460 CAPSULE in 1 BOTTLE (71335-1123-4) 60 capsule2020-11-180000-00-00NoNoCurrent
71335-1123-571335112305100 CAPSULE in 1 BOTTLE (71335-1123-5) 100 capsule2022-05-020000-00-00NoNoCurrent
71335-1123-67133511230614 CAPSULE in 1 BOTTLE (71335-1123-6) 14 capsule2019-03-070000-00-00NoNoCurrent
71335-1123-771335112307120 CAPSULE in 1 BOTTLE (71335-1123-7) 120 capsule2022-05-020000-00-00NoNoCurrent
71335-1123-87133511230890 CAPSULE in 1 BOTTLE (71335-1123-8) 90 capsule2022-05-020000-00-00NoNoCurrent
71335-1123-97133511230915 CAPSULE in 1 BOTTLE (71335-1123-9) 15 capsule2022-05-020000-00-00NoNoCurrent