FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
71335-0046
11-digit product format
713350046
Labeler code
71335
Product ID
71335-0046_b2f1e2a2-87a1-4b4d-b17f-b8dd4af7f24a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2026-12-31

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
71335-0046-0Minocycline Hydrochloride50 in 1 BOTTLECAPSULE5011
71335-0046-1Minocycline Hydrochloride20 in 1 BOTTLECAPSULE2011
71335-0046-2Minocycline Hydrochloride30 in 1 BOTTLECAPSULE3011
71335-0046-3Minocycline Hydrochloride28 in 1 BOTTLECAPSULE2811
71335-0046-4Minocycline Hydrochloride60 in 1 BOTTLECAPSULE6011
71335-0046-5Minocycline Hydrochloride100 in 1 BOTTLECAPSULE10011
71335-0046-6Minocycline Hydrochloride14 in 1 BOTTLECAPSULE1411
71335-0046-7Minocycline Hydrochloride120 in 1 BOTTLECAPSULE12011
71335-0046-8Minocycline Hydrochloride90 in 1 BOTTLECAPSULE9011
71335-0046-9Minocycline Hydrochloride15 in 1 BOTTLECAPSULE1511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0046-0EA - Each71335-0046ae28c658-52bf-4b27-802c-e044dee1081d12018-03-08
71335-0046-1EA - Each71335-0046b20d5220-232f-40d9-a156-ff63b0912add12018-03-08
71335-0046-2EA - Each71335-0046494fcf87-2b0f-477d-9816-e28246d06afb12018-03-08
71335-0046-3EA - Each71335-004607143e2a-0e28-43c3-8235-9da4909bfcd612018-03-08
71335-0046-4EA - Each71335-004691683e9c-b592-4b55-be28-e338dc3af54b12018-03-08
71335-0046-5EA - Each71335-004693657917-b932-4e26-9ce1-66ebe150857812018-03-08
71335-0046-6EA - Each71335-0046bad15d3e-fc0b-4f80-9371-3b3f6a4afabf12018-03-08
71335-0046-7EA - Each71335-0046d3625cf9-e1ec-4fa6-b576-abc029a1890412018-03-08
71335-0046-8EA - Each71335-004608e293a0-eef2-411a-bd78-62a79ef06d9512018-03-08
71335-0046-9EA - Each71335-00469961c854-e883-4de3-9660-ef7e992f90d312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0046MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240913_65767ae3-b1ed-4492-90f2-703b2c7e0f38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN65767ae3-b1ed-4492-90f2-703b2c7e0f3811
197984minocycline 100 MG Oral CapsuleSCD65767ae3-b1ed-4492-90f2-703b2c7e0f3811
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY65767ae3-b1ed-4492-90f2-703b2c7e0f3811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0046-07133500460050 CAPSULE in 1 BOTTLE (71335-0046-0) 50 capsule2024-04-110000-00-00NoNoCurrent
71335-0046-17133500460120 CAPSULE in 1 BOTTLE (71335-0046-1) 20 capsule2018-06-190000-00-00NoNoCurrent
71335-0046-27133500460230 CAPSULE in 1 BOTTLE (71335-0046-2) 30 capsule2018-05-070000-00-00NoNoCurrent
71335-0046-37133500460328 CAPSULE in 1 BOTTLE (71335-0046-3) 28 capsule2024-09-050000-00-00NoNoCurrent
71335-0046-47133500460460 CAPSULE in 1 BOTTLE (71335-0046-4) 60 capsule2020-05-130000-00-00NoNoCurrent
71335-0046-571335004605100 CAPSULE in 1 BOTTLE (71335-0046-5) 100 capsule2024-09-050000-00-00NoNoCurrent
71335-0046-67133500460614 CAPSULE in 1 BOTTLE (71335-0046-6) 14 capsule2018-10-010000-00-00NoNoCurrent
71335-0046-771335004607120 CAPSULE in 1 BOTTLE (71335-0046-7) 120 capsule2024-09-050000-00-00NoNoCurrent
71335-0046-87133500460890 CAPSULE in 1 BOTTLE (71335-0046-8) 90 capsule2018-04-270000-00-00NoNoCurrent
71335-0046-97133500460915 CAPSULE in 1 BOTTLE (71335-0046-9) 15 capsule2024-09-050000-00-00NoNoCurrent