Application 011153

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEDROL	METHYLPREDNISOLONE	TABLET;ORAL	4MG	Yes	No
002	MEDROL	METHYLPREDNISOLONE	TABLET;ORAL	2MG	Yes	No
003	MEDROL	METHYLPREDNISOLONE	TABLET;ORAL	16MG	Yes	No
004	MEDROL	METHYLPREDNISOLONE	TABLET;ORAL	8MG	Yes	No
005	MEDROL	METHYLPREDNISOLONE	TABLET;ORAL	24MG	No	No
006	MEDROL	METHYLPREDNISOLONE	TABLET;ORAL	32MG	Yes	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…`

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): 59762-0049 ndc (product): 59762-0050 ndc (product): 59762-0051 ndc (product): 59762-4440
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 ndc (product): 68071-2370
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 ndc (product): 0009-0073 ndc (product): 0009-0022 ndc (product): 0009-0056 ndc (product): 0009-0176 ndc (product): 0009-0020
Methylprednisolone	METHYLPREDNISOLONE	REMEDYREPACK INC.	d2a0e52c-f724-40e6-9d2a-5f1487c104b6	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011153 application number: NDA011153

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0020	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0020	Medrol	methylprednisolone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0020	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0022	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0022	Medrol	methylprednisolone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0022	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0056	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0056	Medrol	methylprednisolone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0056	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0073	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0073	Medrol	methylprednisolone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0073	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0176	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0176	Medrol	methylprednisolone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0176	Medrol	methylprednisolone	Pharmacia and Upjohn Company LLC	NDA	Current
49999-153	Methylprednisolone	methylprednisolone	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49999-153	Methylprednisolone	methylprednisolone	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49999-153	Methylprednisolone	methylprednisolone	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49999-153	Methylprednisolone	methylprednisolone	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-0092	Medrol	methylprednisolone	A-S Medication Solutions	NDA	Current
50090-0092	Medrol	methylprednisolone	A-S Medication Solutions	NDA	Current
50090-0092	Medrol	methylprednisolone	A-S Medication Solutions	NDA	Current
59762-0049	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0049	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0049	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0050	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0050	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0050	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0051	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0051	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0051	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4440	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4440	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4440	Methylprednisolone	methylprednisolone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
68071-2370	Methylprednisolone	methylprednisolone	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68387-170	Methylprednisolone	methylprednisolone	Keltman Pharmaceuticals Inc.	NDA	Current
70518-2041	Medrol	methylprednisolone	REMEDYREPACK INC.	NDA	Current
70518-2041	Medrol	methylprednisolone	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84122	SUPPL	2025-11-07
84066	SUPPL	2025-11-05
78704	SUPPL	2024-06-07
78672	SUPPL	2024-06-06
77106	SUPPL	2023-12-22
77098	SUPPL	2023-12-21
66314	SUPPL	2021-02-22
66204	SUPPL	2021-02-12
54996	SUPPL	2018-07-26
54965	SUPPL	2018-07-25
33035	SUPPL	2015-12-31