Methylprednisolone

Product NDC: 68084-149
11-digit product format: 680840149
Labeler code: 68084
Product ID: 68084-149_2b248f3e-121b-f738-e063-6294a90a264d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA040183
Marketing category: ANDA
Marketing start: 2013-12-03
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040183-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB		1998-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040183-001	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 2 · 41 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	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040183-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1998-12-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A040183-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040183-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040183-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040183-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040183-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040183-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040183-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040183-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040183-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040183-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040183-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040183-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040183-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040183-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040183-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040183-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040183-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040183-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040183-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040183-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040183-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040183-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040183-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040183-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040183-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040183-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040183-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040183-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040183-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040183-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040183-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040183-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040183-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040183-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040183-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040183-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040183-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040183-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040183-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040183-001	AB	1	`cb3db0bc1861…`

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
97256c7e-5694-4148-926f-594b9d5c34f4	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
68084-149-01	Methylprednisolone	100 in 1 BOX, UNIT-DOSE	TABLET	100		10
68084-149-11	Methylprednisolone	1 in 1 BLISTER PACK	TABLET	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-149-01	EA - Each	68084-149	c3caf1b8-158b-4d32-9f02-c6c63d42564d	1	2013-12-02
68084-149-11	EA - Each	68084-149	8aba13eb-957c-4d62-878d-15b4de0f1b82	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPREDNISOLONE	ACTIVE INGREDIENT	X4W7ZR7023	METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]	2
METHYLPREDNISOLONE	ACTIVE MOIETY	X4W7ZR7023	METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-149	METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]	10	Current NDC, Legacy NDC, 2 package rows	20250109_97256c7e-5694-4148-926f-594b9d5c34f4.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone	METHYLPREDNISOLONE	American Health Packaging	97256c7e-5694-4148-926f-594b9d5c34f4	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040183 application number: ANDA040183 ndc (product): 68084-149
MethylPREDNISolone	METHYLPREDNISOLONE	Par Health USA, LLC	c84cf5e6-746d-41fb-b3d8-2c0b8ba989af	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040183 application number: ANDA040183
MethylPREDNISolone	METHYLPREDNISOLONE	PD-Rx Pharmaceuticals, Inc.	a14c4f76-6dd5-4c84-b6e5-e5abf19ab559	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040183 application number: ANDA040183
MethylPREDNISolone	METHYLPREDNISOLONE	Bryant Ranch Prepack	01f0126c-da22-4ac0-8755-3bc589602e6a	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040183 application number: ANDA040183
MethylPREDNISolone	METHYLPREDNISOLONE	Bryant Ranch Prepack	cbe5f72a-b0fb-4abb-abfe-2f917d351a00	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040183 application number: ANDA040183
MethylPREDNISolone	METHYLPREDNISOLONE	Bryant Ranch Prepack	56c24076-3d5e-4235-a787-ec6329497084	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040183 application number: ANDA040183

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	97256c7e-5694-4148-926f-594b9d5c34f4	10
259966	methylprednisolone 4 MG Oral Tablet	SCD	97256c7e-5694-4148-926f-594b9d5c34f4	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-149-01	68084014901	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-149-01) / 1 TABLET in 1 BLISTER PACK (68084-149-11)	100 blister pack	2013-12-03	0000-00-00	No	No	Current
68084-149-11	68084014911	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Tablets, USP 8214901/1025 Rx only	American Health Packaging	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	11