Methylprednisolone

Product NDC: 76420-041
Requested package NDC: 76420-041-21
11-digit product format: 764200041
Labeler code: 76420
Product ID: 76420-041_ead14e8e-059c-1ebb-e053-2995a90a78b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA040189
Marketing category: ANDA
Marketing start: 1997-10-31
Substance: METHYLPREDNISOLONE
Active strength: 4 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040189-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31
A040189-002	METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31
A040189-003	METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20
A040189-004	METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040189-001	AB
A040189-002	AB
A040189-003	AB
A040189-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A040189-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040189-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040189-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259966	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
8bfdc471-54f7-4298-ba2f-e5c1f6c48456	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
76420-041-21	Methylprednisolone	21 in 1 BLISTER PACK	TABLET	21		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-041-21	EA - Each	76420-041	e8c7bbdc-fcb0-4efd-81b5-fd705585977e	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-041	METHYLPREDNISOLONE TABLET [ASCLEMED USA, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20221013_8bfdc471-54f7-4298-ba2f-e5c1f6c48456.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	Advanced Rx Pharmacy of Tennessee, LLC	f19f3676-856f-e8d7-e053-2995a90ad703	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189
Methylprednisolone	METHYLPREDNISOLONE	A-S Medication Solutions	eb479561-142d-410c-84b2-988375c6a96e	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189
Methylprednisolone	METHYLPREDNISOLONE	Proficient Rx LP	283a913e-f737-478e-b6a0-e050fb6562d8	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189
Methylprednisolone	METHYLPREDNISOLONE	Asclemed USA, Inc.	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189 ndc (package): 76420-041-21 ndc (product): 76420-041 ndc11 (package): 76420004121

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	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2
762675	methylPREDNISolone 4 MG Tablet 6 Day 21 Count Pack	PSN	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2
259966	methylprednisolone 4 MG Oral Tablet	SCD	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2
762675	methylprednisolone 4 MG Oral Tablet 21 Count Pack	SY	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-041-21	76420004121	21 TABLET in 1 BLISTER PACK (76420-041-21)	21 tablet	2020-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHYLPREDNISOLONE TABLETS, USP Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2