FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
57664-853
11-digit product format
576640853
Labeler code
57664
Product ID
57664-853_330a0641-aaa9-e9c1-e063-6294a90ada9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090867
Marketing category
ANDA
Marketing start
2013-05-13
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U

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
57664-853-13Minocycline Hydrochloride500 in 1 BOTTLECAPSULE5006
57664-853-85Minocycline Hydrochloride50 in 1 BOTTLECAPSULE506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-853-85EA - Each57664-853d9459385-15b0-4ae2-b363-6146fa49d3b512013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-853MINOCYCLINE HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 2 package rows20250427_ddd14292-3e39-4f2d-92f2-e7a6253f200a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN49e65b60-ffc9-4ccd-9aec-29a462358d272
197984minocycline 100 MG Oral CapsuleSCD49e65b60-ffc9-4ccd-9aec-29a462358d272
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY49e65b60-ffc9-4ccd-9aec-29a462358d272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-853-1357664085313500 CAPSULE in 1 BOTTLE (57664-853-13) 500 capsule2013-05-130000-00-00NoNoCurrent
57664-853-855766408538550 CAPSULE in 1 BOTTLE (57664-853-85) 50 capsule2013-05-130000-00-00NoNoCurrent