FDA.reportPublic FDA data

amantadine hydrochloride

Product NDC
68382-512
11-digit product format
683820512
Labeler code
68382
Product ID
68382-512_6e270f1c-83bd-4c12-a810-69f7c797fd61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA208278
Marketing category
ANDA
Marketing start
2016-08-04
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
amantadine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6Q1EO9TD0
Rxcui849389

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
519d6abc-639d-2962-cced-abbf8b16aad4Product name720250401
82f46845-b4c7-48da-a389-ba5721b956c9Product name220250325
d2c037c0-5ebf-d224-252f-2549922c21c7Product name720240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-512-01amantadine hydrochloride100 in 1 BOTTLECAPSULE1007
68382-512-05amantadine hydrochloride500 in 1 BOTTLECAPSULE5007
68382-512-06amantadine hydrochloride30 in 1 BOTTLECAPSULE307
68382-512-30amantadine hydrochloride10 in 1 BLISTER PACKCAPSULE107
68382-512-77amantadine hydrochloride10 in 1 CARTONCAPSULE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-512-01EA - Each68382-5123e1611d8-9921-4931-810f-0bc67ff5b9da12016-10-06
68382-512-05EA - Each68382-512dd26e991-f46b-408d-884f-8c32c781e35612016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-512AMANTADINE HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]6Current NDC, Legacy NDC, 5 package rows20250410_609dc911-1e9d-4ebd-b64b-f44054e5582e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN8e578f11-6112-4a1f-8de4-a76870bb62c78
849389amantadine hydrochloride 100 MG Oral CapsuleSCD8e578f11-6112-4a1f-8de4-a76870bb62c78
849389amantadine HCl 100 MG Oral CapsulePSN609dc911-1e9d-4ebd-b64b-f44054e5582e7
849389amantadine hydrochloride 100 MG Oral CapsuleSCD609dc911-1e9d-4ebd-b64b-f44054e5582e7
849389amantadine HCl 100 MG Oral CapsulePSN2cb6e83d-e635-b150-e063-6294a90ad61d1
849389amantadine HCl 100 MG Oral CapsulePSN743d1b73-f47e-4bbf-bb52-45b1e7f173081
849389amantadine hydrochloride 100 MG Oral CapsuleSCD2cb6e83d-e635-b150-e063-6294a90ad61d1
849389amantadine hydrochloride 100 MG Oral CapsuleSCD743d1b73-f47e-4bbf-bb52-45b1e7f173081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-512-0168382051201100 CAPSULE in 1 BOTTLE (68382-512-01) 100 capsule2016-08-040000-00-00NoNoCurrent
68382-512-0568382051205500 CAPSULE in 1 BOTTLE (68382-512-05) 500 capsule2016-08-040000-00-00NoNoCurrent
68382-512-066838205120630 CAPSULE in 1 BOTTLE (68382-512-06) 30 capsule2016-08-040000-00-00NoNoCurrent
68382-512-306838205123010 in 1 BLISTER PACKHistorical
68382-512-776838205127710 BLISTER PACK in 1 CARTON (68382-512-77) / 10 CAPSULE in 1 BLISTER PACK (68382-512-30) 10 blister pack2016-08-040000-00-00NoNoCurrent