Methylprednisolone

Product NDC: 62135-761
11-digit product format: 621350761
Labeler code: 62135
Product ID: 62135-761_225669c1-9479-52eb-e063-6394a90a649b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA209097
Marketing category: ANDA
Marketing start: 2019-02-22
Substance: METHYLPREDNISOLONE
Active strength: 8 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPREDNISOLONE	8 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
197969	Internal RxNorm lookup
197971	Internal RxNorm lookup
197973	Internal RxNorm lookup
259966	Internal RxNorm lookup
328161	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
bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	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
62135-761-26	Methylprednisolone	25 in 1 BOTTLE	TABLET	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-761-26	EA - Each	62135-761	23aa5285-dd23-477d-81da-f03c69f03420	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-761	METHYLPREDNISOLONE TABLET [CHARTWELL RX, LLC]	2	Current NDC, 1 package rows	20240919_bdd048bb-7e6c-45c7-b51a-075e83ca9f5b.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 ndc (product): 62135-761

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
328161	methylPREDNISolone 16 MG Oral Tablet	PSN	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
197969	methylPREDNISolone 2 MG Oral Tablet	PSN	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
197971	methylPREDNISolone 32 MG Oral Tablet	PSN	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
197973	methylPREDNISolone 8 MG Oral Tablet	PSN	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
328161	methylprednisolone 16 MG Oral Tablet	SCD	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
197969	methylprednisolone 2 MG Oral Tablet	SCD	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
197971	methylprednisolone 32 MG Oral Tablet	SCD	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
259966	methylprednisolone 4 MG Oral Tablet	SCD	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2
197973	methylprednisolone 8 MG Oral Tablet	SCD	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-761-26	62135076126	25 TABLET in 1 BOTTLE (62135-761-26)	25 tablet	2024-05-14	No	No	Current