Methylprednisolone

Product NDC
62135-759
11-digit product format
621350759
Labeler code
62135
Product ID
62135-759_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
2 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209097-001METHYLPREDNISOLONEMETHYLPREDNISOLONE2MGTABLET / ORAL2019-02-22
A209097-002METHYLPREDNISOLONEMETHYLPREDNISOLONE4MGTABLET / ORAL2019-02-22
A209097-003METHYLPREDNISOLONEMETHYLPREDNISOLONE8MGTABLET / ORAL2019-02-22
A209097-004METHYLPREDNISOLONEMETHYLPREDNISOLONE16MGTABLET / ORAL2019-02-22
A209097-005METHYLPREDNISOLONEMETHYLPREDNISOLONE32MGTABLET / ORAL2019-02-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209097-001METHYLPREDNISOLONE2MGTABLET / ORAL2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209097-002METHYLPREDNISOLONE4MGTABLET / ORAL2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209097-003METHYLPREDNISOLONE8MGTABLET / ORAL2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209097-004METHYLPREDNISOLONE16MGTABLET / ORAL2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209097-005METHYLPREDNISOLONE32MGTABLET / ORAL2019-02-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A209097-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209097-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209097-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209097-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209097-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209097-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209097-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209097-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209097-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209097-005AB1ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4W7ZR7023Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197969Internal RxNorm lookup
197971Internal RxNorm lookup
197973Internal RxNorm lookup
259966Internal RxNorm lookup
328161Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdd048bb-7e6c-45c7-b51a-075e83ca9f5bAvailable on FDA.report

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
62135-759-30Methylprednisolone30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-759METHYLPREDNISOLONE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20240919_bdd048bb-7e6c-45c7-b51a-075e83ca9f5b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethylprednisoloneMETHYLPREDNISOLONEChartwell RX, LLCbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2024-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209097
application number: ANDA209097
ndc (product): 62135-759

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
62135-759-306213507593030 TABLET in 1 BOTTLE (62135-759-30) 30 tablet2024-05-14NoNoCurrent