FDA.reportPublic FDA data

METHYLPREDNISOLONE ACETATE

Product NDC
0781-3522
Requested package NDC
0781-3522-75
11-digit product format
007813522
Labeler code
0781
Product ID
0781-3522_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
2024-03-14
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-35220781-3522-75IInactivated by FDA2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214870-001METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03
A214870-002METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214870-001AB
A214870-002AB

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 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-108072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-036a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-031c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-039b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214870-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2023-01-03a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214870-002METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2023-05-10a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214870-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214870-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214870-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214870-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214870-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214870-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214870-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214870-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214870-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214870-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214870-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214870-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214870-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214870-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214870-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214870-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214870-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214870-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214870-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214870-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214870-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214870-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214870-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214870-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214870-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214870-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214870-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214870-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214870-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214870-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214870-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214870-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214870-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214870-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214870-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214870-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214870-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214870-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214870-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214870-002AB1a67488948f0b…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3522-75Physicians EZ Use M-pred1 in 1 CARTONINJECTION, SUSPENSION40 mg in 1mL13
0781-3522-75Physicians EZ Use M-pred5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION5 mL40 mg in 1mL13
0781-3522-70METHYLPREDNISOLONE ACETATE1 in 1 CARTONINJECTION, SUSPENSION17
0781-3522-70METHYLPREDNISOLONE ACETATE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION107
0781-3522-75METHYLPREDNISOLONE ACETATE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION57
0781-3522-75METHYLPREDNISOLONE ACETATE1 in 1 CARTONINJECTION, SUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3522-70ML - Milliliter0781-352253f54dea-4c98-44de-9e35-e98d5cb92a6312024-04-05
0781-3522-75ML - Milliliter0781-3522825ee41e-5c96-47b1-8436-31799cc3c45412024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
METHYLPREDNISOLONE ACETATEACTIVE INGREDIENT43502P7F0PPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
BUPIVACAINEACTIVE MOIETYY8335394ROPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
IODINEACTIVE MOIETY9679TC07X4PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1
WATERINACTIVE INGREDIENT059QF0KO0RPHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3522PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [ASCLEMED USA, INC.]13Current NDC20241101_dec92845-e713-42a3-83a7-3a48920b7eed.zip
0781-3522METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [SANDOZ INC.]7Current NDC, 4 package rows20240316_a363f0cd-9c8e-4622-9271-171706846b96.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Physicians EZ Use M-predMETHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINEAsclemed USA, Inc.dec92845-e713-42a3-83a7-3a48920b7eed2024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0781-3522-75
ndc11 (package): 00781352275

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNdec92845-e713-42a3-83a7-3a48920b7eed13
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNdec92845-e713-42a3-83a7-3a48920b7eed13
797730povidone-iodine 10 % Medicated PadPSNdec92845-e713-42a3-83a7-3a48920b7eed13
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDdec92845-e713-42a3-83a7-3a48920b7eed13
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDdec92845-e713-42a3-83a7-3a48920b7eed13
797730povidone-iodine 100 MG/ML Medicated PadSCDdec92845-e713-42a3-83a7-3a48920b7eed13
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYdec92845-e713-42a3-83a7-3a48920b7eed13
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYdec92845-e713-42a3-83a7-3a48920b7eed13
797730povidone-iodine 10 % Medicated PadSYdec92845-e713-42a3-83a7-3a48920b7eed13
797730povidone-iodine 10 % Medicated SwabstickSYdec92845-e713-42a3-83a7-3a48920b7eed13
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNa363f0cd-9c8e-4622-9271-171706846b967
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSNa363f0cd-9c8e-4622-9271-171706846b967
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDa363f0cd-9c8e-4622-9271-171706846b967
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCDa363f0cd-9c8e-4622-9271-171706846b967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0781-3522-75007813522751 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-75) / 5 mL in 1 VIAL, MULTI-DOSE2024-03-14NoNoHistorical