METHYLPREDNISOLONE

Product NDC: 85509-1400
11-digit product format: 855091400
Labeler code: 85509
Product ID: 85509-1400_476ef63e-5c25-17ed-e063-6394a90af4f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHYLPREDNISOLONE
Dosage form: TABLET
Route: ORAL
Labeler: PHOENIX RX LLC
Application: ANDA204072
Marketing category: ANDA
Marketing start: 2018-05-14
Substance: METHYLPREDNISOLONE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A204072-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB		2018-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204072-001	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	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`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	A204072-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204072-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204072-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204072-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204072-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204072-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204072-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204072-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204072-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204072-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204072-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204072-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204072-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204072-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204072-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204072-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204072-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204072-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204072-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204072-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204072-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204072-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204072-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204072-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204072-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204072-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204072-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204072-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204072-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204072-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204072-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204072-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204072-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204072-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204072-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204072-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204072-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204072-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204072-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204072-001	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 · 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
476ef50d-7e77-75f6-e063-6294a90a26e4	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
85509-1400-2	METHYLPREDNISOLONE	1 in 1 CARTON	TABLET	1		1
85509-1400-2	METHYLPREDNISOLONE	21 in 1 BLISTER PACK	TABLET	21		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85509-1400-2	EA - Each	85509-1400	cba3c742-775c-4645-8447-6ec17bc86be4	1	2026-02-05

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYLPREDNISOLONE	METHYLPREDNISOLONE	HAWAII REPACK, INC.	d0d5fc54-69e1-4303-96be-3f97adec6074	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Preferred Pharmaceuticals Inc.	e27ab941-adc6-47b6-b217-08d095a851fd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	St. Mary's Medical Park Pharmacy	235ca8cf-1576-0dfd-e063-6394a90a8b25	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	REMEDYREPACK INC.	445e59a6-8886-48e7-8116-253a82144934	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Sportpharm LLC	fd9f28a0-fd86-4767-876c-8520fddeccd2	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Tianjin Tianyao Pharmaceuticals Co., Ltd.	e09eefd2-f423-40cb-87b6-3ee97e7f831b	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	PHOENIX RX LLC	476ef50d-7e77-75f6-e063-6294a90a26e4	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 85509-1400
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Epic Pharma, LLC	b1908c2a-c596-4e2a-b2bd-0745d4fea31a	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Direct_Rx	8c3f3f63-8a05-7a4a-e053-2995a90ad95a	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
Methylprednisolone	METHYLPREDNISOLONE	Advanced Rx Pharmacy of Tennessee, LLC	f19f4304-bf37-da04-e053-2a95a90a4044	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	a1dae00d-1ad3-7493-e053-2a95a90af49f	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Proficient Rx LP	3e37236f-8ba8-4a1c-87c8-62b787890fae	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Doc Rx	c6ec50b5-aeb8-40c3-83e2-af4fe8fefb14	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Asclemed USA, Inc.	8bff5330-c1f6-4014-aadb-45c1726248dd	2021-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072

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	476ef50d-7e77-75f6-e063-6294a90a26e4	1
259966	methylprednisolone 4 MG Oral Tablet	SCD	476ef50d-7e77-75f6-e063-6294a90a26e4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85509-1400-2	85509140002	1 BLISTER PACK in 1 CARTON (85509-1400-2) / 21 TABLET in 1 BLISTER PACK	1 blister pack	2026-01-02	No	No	Current