Methylprednisolone

Product NDC: 68071-2370
11-digit product format: 680712370
Labeler code: 68071
Product ID: 68071-2370_4b45622d-5003-33a3-e063-6394a90afb6e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: NDA011153
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2011-10-11
Substance: METHYLPREDNISOLONE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2370-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-2370-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-2370-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-2370-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-2370-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-2370-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-2370-1	`1332a3947898…`	`d4bfe170f9cd…`

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	4 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259966	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
bdd233d9-333d-7389-e053-2a95a90a4b42	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2370-1	2025-01-14	C162847	48780-1	f386c64a-1670-0266-e053-dadaa90a7c1a	Methylprednisolone Tablets, USP
68071-2370-1	2023-01-30	C162847	48780-1	f386c64a-1670-0266-e053-dadaa90a7c1a	Methylprednisolone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2370-1	Methylprednisolone	21 in 1 DOSE PACK	TABLET	21		3
68071-2370-1	Methylprednisolone	1 in 1 CARTON	TABLET	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2370	METHYLPREDNISOLONE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 2 package rows	20250116_bdd233d9-333d-7389-e053-2a95a90a4b42.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
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
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
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	bdd233d9-333d-7389-e053-2a95a90a4b42	3
259966	methylprednisolone 4 MG Oral Tablet	SCD	bdd233d9-333d-7389-e053-2a95a90a4b42	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2370-1	68071237001	1 DOSE PACK in 1 CARTON (68071-2370-1) / 21 TABLET in 1 DOSE PACK	1 dose pack	2021-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Tablets, USP	NuCare Pharmaceuticals,Inc.	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	3