methylprednisolone

Product NDC: 68180-687
11-digit product format: 681800687
Labeler code: 68180
Product ID: 68180-687_c71a649a-a46d-4e69-81b8-f65e77a4c48b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA209097
Marketing category: ANDA
Marketing start: 2020-03-01
Marketing end: 0000-00-00
Substance: METHYLPREDNISOLONE
Active strength: 8 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A209097-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22
A209097-002	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22
A209097-003	METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22
A209097-004	METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22
A209097-005	METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209097-001	METHYLPREDNISOLONE	2MG	TABLET / ORAL	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209097-002	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209097-003	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209097-004	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209097-005	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2019-02-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A209097-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209097-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209097-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209097-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209097-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209097-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209097-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209097-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209097-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209097-005	AB	1	`ea99ee380514…`

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
68180-687-55	methylprednisolone	25 in 1 BOTTLE	TABLET	25		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-687	METHYLPREDNISOLONE TABLET [LUPIN PHARMACEUTICALS, INC.]	7	Legacy NDC, 1 package rows	20211209_c5cbcea1-2200-4fc0-a49a-35edd9434873.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone	METHYLPREDNISOLONE	Chartwell RX, LLC	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2024-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209097 application number: ANDA209097

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	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
328161	methylPREDNISolone 16 MG Oral Tablet	PSN	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
197969	methylPREDNISolone 2 MG Oral Tablet	PSN	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
197971	methylPREDNISolone 32 MG Oral Tablet	PSN	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
762675	methylPREDNISolone 4 MG Tablet 6 Day 21 Count Pack	PSN	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
197973	methylPREDNISolone 8 MG Oral Tablet	PSN	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
328161	methylprednisolone 16 MG Oral Tablet	SCD	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
197969	methylprednisolone 2 MG Oral Tablet	SCD	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
197971	methylprednisolone 32 MG Oral Tablet	SCD	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
259966	methylprednisolone 4 MG Oral Tablet	SCD	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
197973	methylprednisolone 8 MG Oral Tablet	SCD	c5cbcea1-2200-4fc0-a49a-35edd9434873	7
762675	methylprednisolone 4 MG Oral Tablet 21 Count Pack	SY	c5cbcea1-2200-4fc0-a49a-35edd9434873	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-687-55	68180068755	25 TABLET in 1 BOTTLE (68180-687-55)	25 tablet	2020-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Tablets USP	Lupin Pharmaceuticals, Inc.	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	7