MethylPREDNISolone

Product NDC: 55045-1259
11-digit product format: 550451259
Labeler code: 55045
Product ID: 55045-1259_93aefabb-b384-40ef-9d3f-f8dee3b21f1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA040183
Marketing category: ANDA
Marketing start: 1998-12-22
Marketing end: 0000-00-00
Substance: METHYLPREDNISOLONE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55045-1259		I	Inactivated by FDA		2026-08-03
excluded package	package	55045-1259	55045-1259-9	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55045-1259-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55045-1259-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55045-1259-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55045-1259-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55045-1259-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55045-1259-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55045-1259-9	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55045-1259-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55045-1259-9	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55045-1259-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55045-1259-9	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55045-1259-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55045-1259-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55045-1259-9	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55045-1259-9	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55045-1259-9	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55045-1259-9	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55045-1259-9	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55045-1259-9	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55045-1259-9	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55045-1259-9	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55045-1259-9	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55045-1259-9	2019-10-29	C162847	48780-1	960f7f55-d052-8e05-e053-dbdaa90a074a	MethylPREDNISolone TABLETS, USP 4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55045-1259-9	MethylPREDNISolone	21 in 1 BOTTLE, PLASTIC	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
55045-1259-9	EA - Each	55045-1259	9cfff942-0a10-42ca-8baa-0be205822886	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55045-1259	METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 1 package rows	20110923_2eb5d8c3-87dd-47dc-9619-461dfb7ba935.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
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
762675	{21 (methylprednisolone 4 MG Oral Tablet) } Pack	GPCK	2eb5d8c3-87dd-47dc-9619-461dfb7ba935	2
259966	methylPREDNISolone 4 MG Oral Tablet	PSN	2eb5d8c3-87dd-47dc-9619-461dfb7ba935	2
762675	methylPREDNISolone 4 MG Tablet 6 Day 21 Count Pack	PSN	2eb5d8c3-87dd-47dc-9619-461dfb7ba935	2
259966	methylprednisolone 4 MG Oral Tablet	SCD	2eb5d8c3-87dd-47dc-9619-461dfb7ba935	2
762675	methylprednisolone 4 MG Oral Tablet 21 Count Pack	SY	2eb5d8c3-87dd-47dc-9619-461dfb7ba935	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55045-1259-9	55045125909	21 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MethylPREDNISolone TABLETS, USP 4 mg	Dispensing Solutions, Inc.	2011-09-22	HUMAN PRESCRIPTION DRUG LABEL	2