FDA.reportPublic FDA data

Methyldopa

Product NDC
62135-322
11-digit product format
621350322
Labeler code
62135
Product ID
62135-322_31442b54-cca3-2834-e063-6294a90aaccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methyldopa
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
NDA018934
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1984-06-29
Substance
METHYLDOPA
Active strength
500 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
METHYLDOPA500 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
62135-322-18Methyldopa180 in 1 BOTTLETABLET, FILM COATED1803
62135-322-90Methyldopa90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-322-18EA - Each62135-322e2a8a711-c29f-4489-81e6-08687242721812023-02-06
62135-322-90EA - Each62135-322d75081f1-1c1a-45c6-a7d6-e8df61cf94ba12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-322METHYLDOPA TABLET, FILM COATED [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 2 package rows20250328_e1114a58-9ab5-486e-85ed-360365b06396.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197956methyldopa 250 MG Oral TabletPSNe1114a58-9ab5-486e-85ed-360365b063963
197958methyldopa 500 MG Oral TabletPSNe1114a58-9ab5-486e-85ed-360365b063963
197956methyldopa 250 MG Oral TabletSCDe1114a58-9ab5-486e-85ed-360365b063963
197958methyldopa 500 MG Oral TabletSCDe1114a58-9ab5-486e-85ed-360365b063963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-322-1862135032218180 TABLET, FILM COATED in 1 BOTTLE (62135-322-18) 2022-11-220000-00-00NoNoCurrent
62135-322-906213503229090 TABLET, FILM COATED in 1 BOTTLE (62135-322-90) 2022-11-220000-00-00NoNoCurrent