METHYLPREDNISOLONE ACETATE

Product NDC: 0781-3516
11-digit product format: 007813516
Labeler code: 0781
Product ID: 0781-3516_ab8910e5-0b8c-4057-a95d-4519ce85835b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHYLPREDNISOLONE ACETATE
Dosage form: INJECTION, SUSPENSION
Route: INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler: Sandoz Inc.
Application: ANDA214870
Marketing category: ANDA
Marketing start: 2023-02-08
Substance: METHYLPREDNISOLONE ACETATE
Active strength: 80 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0781-3516		I	Inactivated by FDA		2026-08-17
excluded package	package	0781-3516	0781-3516-75	I	Inactivated by FDA		2026-08-17

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214870-001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB		2023-01-03
A214870-002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB		2023-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214870-001	AB
A214870-002	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 · 48 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
2026-08-18 06:07:40	2026-07	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214870-001	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2023-01-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214870-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2023-05-10	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214870-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214870-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214870-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214870-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214870-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214870-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214870-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214870-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214870-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214870-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214870-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214870-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214870-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214870-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214870-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214870-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214870-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214870-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214870-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214870-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214870-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214870-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214870-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214870-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214870-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214870-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214870-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214870-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214870-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214870-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214870-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214870-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214870-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214870-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214870-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214870-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214870-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214870-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214870-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214870-002	AB	1	`9b2671bbb829…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26	Product name	5	20260128
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e1637c7c-52c4-49a3-b36b-61be755aab29	Product name	4	20230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815	Product name	4	20220316
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-3516-75	METHYLPREDNISOLONE ACETATE	1 in 1 CARTON	INJECTION, SUSPENSION	1		7
0781-3516-75	METHYLPREDNISOLONE ACETATE	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	5		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3516-75	ML - Milliliter	0781-3516	1bf54819-729b-4fc1-85da-a495523e34e9	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3516	METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [SANDOZ INC.]	7	Current NDC, 2 package rows	20240316_a363f0cd-9c8e-4622-9271-171706846b96.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
43502P7F0P	METHYLPREDNISOLONE ACETATE	53-36-1	METHYLPREDNISOLONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1358610	methylPREDNISolone acetate 40 MG/ML Injectable Suspension	PSN	a363f0cd-9c8e-4622-9271-171706846b96	7
1358617	methylPREDNISolone acetate 80 MG/ML Injectable Suspension	PSN	a363f0cd-9c8e-4622-9271-171706846b96	7
1358610	methylprednisolone acetate 40 MG/ML Injectable Suspension	SCD	a363f0cd-9c8e-4622-9271-171706846b96	7
1358617	methylprednisolone acetate 80 MG/ML Injectable Suspension	SCD	a363f0cd-9c8e-4622-9271-171706846b96	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0781-3516-75	00781351675	1 VIAL, MULTI-DOSE in 1 CARTON (0781-3516-75) / 5 mL in 1 VIAL, MULTI-DOSE	2023-02-08	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Acetate Injectable Suspension, USP	REMEDYREPACK INC.	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Methylprednisolone Acetate Injectable Suspension, USP	Sandoz Inc. \| Lisapharma SPA	2024-03-01	Human Prescription Drug Label	7