Methyldopa

Product NDC
64980-571
11-digit product format
649800571
Labeler code
64980
Product ID
64980-571_807ace4b-b2af-44b4-9371-884d73e21601
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methyldopa
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA070076
Marketing category
ANDA
Marketing start
2025-04-04
Substance
METHYLDOPA
Active strength
250 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLDOPA250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56LH93261Y
Rxcui197956, 197958

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
512b4ef2-bf6c-5103-2bac-fd8ec25453adProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-571-01Methyldopa100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-571-01EA - Each64980-57181cd9776-0113-45e3-ae52-82fd8acfaab312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-571METHYLDOPA TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, 1 package rows20250406_9e22e1d8-04ec-4b67-92ea-b09c706f2703.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197956methyldopa 250 MG Oral TabletPSN9e22e1d8-04ec-4b67-92ea-b09c706f27033
197958methyldopa 500 MG Oral TabletPSN9e22e1d8-04ec-4b67-92ea-b09c706f27033
197956methyldopa 250 MG Oral TabletSCD9e22e1d8-04ec-4b67-92ea-b09c706f27033
197958methyldopa 500 MG Oral TabletSCD9e22e1d8-04ec-4b67-92ea-b09c706f27033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-571-0164980057101100 TABLET in 1 BOTTLE (64980-571-01) 100 tablet2025-04-04NoNoCurrent