Methylprednisolone

Product NDC: 65162-982
11-digit product format: 651620982
Labeler code: 65162
Product ID: 65162-982_cccbff06-b0eb-4a4d-8553-79a458e27765
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA207481
Marketing category: ANDA
Marketing start: 2015-05-29
Marketing end: 0000-00-00
Substance: METHYLPREDNISOLONE
Active strength: 16 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65162-982		D	Discontinued by firm	2026-09-09
excluded package	package	65162-982	65162-982-05	D	Discontinued by firm	2026-09-09
excluded package	package	65162-982	65162-982-29	D	Discontinued by firm	2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A207481-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21
A207481-002	METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21
A207481-003	METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21
A207481-004	METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21

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 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207481-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	2021-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207481-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	2021-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207481-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	2021-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207481-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	2021-09-21	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A207481-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207481-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207481-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207481-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207481-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207481-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207481-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207481-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207481-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207481-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207481-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207481-004	AB	1	`782e0a99824c…`

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-982	METHYLPREDNISOLONE TABLET [AMNEAL PHARMACEUTICALS LLC]	10	Legacy NDC	20240719_bf3e59c2-c080-48c0-8910-5fdba1ec7dd6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4W7ZR7023	METHYLPREDNISOLONE	83-43-2	METHYLPREDNISOLONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-982-05	65162098205	50 TABLET in 1 BOTTLE (65162-982-05)	50 tablet	2015-05-29	0000-00-00	No	No	Current
65162-982-29	65162098229	25 TABLET in 1 BOTTLE (65162-982-29)	25 tablet	2015-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Tablets, USP 4 mg, 8 mg, 16 mg and 32 mg Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2025-11-21	HUMAN PRESCRIPTION DRUG LABEL	11