Methylprednisolone

Product NDC: 59762-0051
11-digit product format: 597620051
Labeler code: 59762
Product ID: 59762-0051_757e97bc-e224-4e63-819b-2f3213428207
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA011153
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-03-25
Substance: METHYLPREDNISOLONE
Active strength: 32 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N011153-001	MEDROL	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011153-002	MEDROL	METHYLPREDNISOLONE	2MG	TABLET / ORAL		RLD, Approved before 1982
N011153-003	MEDROL	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011153-004	MEDROL	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011153-005	MEDROL	METHYLPREDNISOLONE	24MG	TABLET / ORAL		Approved before 1982
N011153-006	MEDROL	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N011153-001	AB
N011153-003	AB
N011153-004	AB
N011153-006	AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-005	MEDROL	24MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-006	MEDROL	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-005	MEDROL	24MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-006	MEDROL	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-005	MEDROL	24MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-006	MEDROL	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-005	MEDROL	24MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-006	MEDROL	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-005	MEDROL	24MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-006	MEDROL	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-005	MEDROL	24MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-006	MEDROL	32MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-001	MEDROL	4MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-002	MEDROL	2MG	TABLET / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-003	MEDROL	16MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-004	MEDROL	8MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 183 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011153-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011153-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011153-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011153-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011153-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011153-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011153-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011153-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011153-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011153-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011153-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011153-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011153-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011153-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011153-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011153-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011153-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011153-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011153-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011153-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011153-006	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylprednisolone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPREDNISOLONE	32 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X4W7ZR7023	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197971	Internal RxNorm lookup
197973	Internal RxNorm lookup
259966	Internal RxNorm lookup
328161	Internal RxNorm lookup
762675	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26	Product name	5	20260128
e1637c7c-52c4-49a3-b36b-61be755aab29	Product name	4	20230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815	Product name	4	20220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59762-0051-1	Methylprednisolone	25 in 1 BOTTLE	TABLET	25		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-0051-1	EA - Each	59762-0051	367b2773-9477-4691-991d-b99a9d2b1824	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPREDNISOLONE	ACTIVE INGREDIENT	X4W7ZR7023	METHYLPREDNISOLONE TABLET [GREENSTONE LLC]	6
METHYLPREDNISOLONE	ACTIVE MOIETY	X4W7ZR7023	METHYLPREDNISOLONE TABLET [GREENSTONE LLC]	6
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	METHYLPREDNISOLONE TABLET [GREENSTONE LLC]	6
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	METHYLPREDNISOLONE TABLET [GREENSTONE LLC]	6
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	METHYLPREDNISOLONE TABLET [GREENSTONE LLC]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHYLPREDNISOLONE TABLET [GREENSTONE LLC]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	METHYLPREDNISOLONE TABLET [GREENSTONE LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-0051	METHYLPREDNISOLONE TABLET [MYLAN PHARMACEUTICALS INC.]	18	Current NDC, Legacy NDC, 1 package rows	20250524_22dd75d6-f89a-44f7-8ca6-b64c4e9806dd.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone	METHYLPREDNISOLONE	Mylan Pharmaceuticals Inc.	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153 ndc (product): 59762-0051
Methylprednisolone	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	bdd233d9-333d-7389-e053-2a95a90a4b42	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153
Medrol	METHYLPREDNISOLONE	Pharmacia & Upjohn Company LLC	39d5270b-d957-4821-93d6-501b7b9f02d4	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153
Methylprednisolone	METHYLPREDNISOLONE	REMEDYREPACK INC.	d2a0e52c-f724-40e6-9d2a-5f1487c104b6	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4W7ZR7023	METHYLPREDNISOLONE	83-43-2	METHYLPREDNISOLONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
762675	{21 (methylprednisolone 4 MG Oral Tablet) } Pack	GPCK	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
328161	methylPREDNISolone 16 MG Oral Tablet	PSN	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
197971	methylPREDNISolone 32 MG Oral Tablet	PSN	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
762675	methylPREDNISolone 4 MG Tablet 6 Day 21 Count Pack	PSN	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
197973	methylPREDNISolone 8 MG Oral Tablet	PSN	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
328161	methylprednisolone 16 MG Oral Tablet	SCD	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
197971	methylprednisolone 32 MG Oral Tablet	SCD	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
259966	methylprednisolone 4 MG Oral Tablet	SCD	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
197973	methylprednisolone 8 MG Oral Tablet	SCD	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
762675	methylprednisolone 4 MG Oral Tablet 21 Count Pack	SY	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	19
197971	methylPREDNISolone 32 MG Oral Tablet	PSN	1eba330b-ce16-6b12-e063-6294a90a8763	1
197971	methylprednisolone 32 MG Oral Tablet	SCD	1eba330b-ce16-6b12-e063-6294a90a8763	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-0051-1	59762005101	25 TABLET in 1 BOTTLE (59762-0051-1)	25 tablet	2013-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Tablets, USP	Mylan Pharmaceuticals Inc. \| Pharmacia & Upjohn Company LLC \| Pfizer Italia S.r.l.	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	20
Methylprednisolone Tablets, USP	RedPharm Drug	2024-08-02	HUMAN PRESCRIPTION DRUG LABEL	1