FDA.reportPublic FDA data

Methylprednisolone

Product NDC
62135-760
11-digit product format
621350760
Labeler code
62135
Product ID
62135-760_225669c1-9479-52eb-e063-6394a90a649b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA209097
Marketing category
ANDA
Marketing start
2019-02-22
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4W7ZR7023
Rxcui197969, 197971, 197973, 259966, 328161

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-760-01Methylprednisolone100 in 1 BOTTLETABLET1002
62135-760-21Methylprednisolone21 in 1 BOTTLETABLET212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-760-01EA - Each62135-7601081792e-7a2e-4784-8f85-3a96aaee7e2a12024-06-10
62135-760-21EA - Each62135-76064b4bb02-bda5-4706-9bea-c31c8d46c7c612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-760METHYLPREDNISOLONE TABLET [CHARTWELL RX, LLC]2Current NDC, 2 package rows20240919_bdd048bb-7e6c-45c7-b51a-075e83ca9f5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
328161methylPREDNISolone 16 MG Oral TabletPSNbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
197969methylPREDNISolone 2 MG Oral TabletPSNbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
197971methylPREDNISolone 32 MG Oral TabletPSNbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
259966methylPREDNISolone 4 MG Oral TabletPSNbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
197973methylPREDNISolone 8 MG Oral TabletPSNbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
328161methylprednisolone 16 MG Oral TabletSCDbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
197969methylprednisolone 2 MG Oral TabletSCDbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
197971methylprednisolone 32 MG Oral TabletSCDbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
259966methylprednisolone 4 MG Oral TabletSCDbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2
197973methylprednisolone 8 MG Oral TabletSCDbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-760-0162135076001100 TABLET in 1 BOTTLE (62135-760-01) 100 tablet2024-05-14NoNoCurrent
62135-760-216213507602121 TABLET in 1 BOTTLE (62135-760-21) 21 tablet2024-05-14NoNoCurrent