FDA.reportPublic FDA data

Methylprednisolone acetate

Product NDC
70121-1574
Requested package NDC
70121-1574-1
11-digit product format
701211574
Labeler code
70121
Product ID
70121-1574_af4215ff-94ca-44f8-8506-3024e738cd13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210043
Marketing category
ANDA
Marketing start
2019-05-20
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210043-001METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20
A210043-002METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210043-001AB
A210043-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20caaa826d4ba7…
2026-08-18 06:07:402026-07A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRS2019-05-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRS2019-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2019-05-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2019-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2019-05-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2019-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2019-05-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2019-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTION2019-05-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTION2019-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210043-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2019-05-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210043-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2019-05-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210043-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210043-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210043-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210043-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210043-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210043-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210043-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210043-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210043-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210043-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210043-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210043-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210043-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210043-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210043-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210043-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210043-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210043-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210043-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210043-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210043-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210043-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210043-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210043-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210043-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210043-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210043-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210043-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210043-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210043-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210043-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210043-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210043-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210043-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210043-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210043-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210043-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210043-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210043-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210043-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43502P7F0PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1743779Internal RxNorm lookup
1743855Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d944240d-2c19-46ba-ad4f-3fbee7b8629cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1574-1Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION116
70121-1574-1Methylprednisolone acetate1 in 1 CARTONINJECTION, SUSPENSION116
70121-1574-5Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION116
70121-1574-5Methylprednisolone acetate25 in 1 CARTONINJECTION, SUSPENSION2516
70121-1574-1Dyural 80 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL11
70121-1574-1Dyural 80 Kit1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL11
70121-1574-1Dyural 80-LM1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL5
70121-1574-1Dyural 80-LM1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL5
70121-1574-1Dyural 80-LM1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL2
70121-1574-1Dyural 80 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL2
70121-1574-1Dyural 80-LM1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL2
70121-1574-1Dyural 80 Kit1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1574-1ML - Milliliter70121-157468b0e5e7-e814-4c98-a6e5-02085339b85812020-08-06
70121-1574-5ML - Milliliter70121-157458ac78fc-2bd4-458a-8aa3-f905f328b61812020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ADYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Methylprednisolone AcetateACTIVE INGREDIENT43502P7F0PDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
BupivacaineACTIVE MOIETYY8335394RODYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
IodineACTIVE MOIETY9679TC07X4DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
LidocaineACTIVE MOIETY98PI200987DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1574METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 4 package rows20250108_d944240d-2c19-46ba-ad4f-3fbee7b8629c.zip
70121-1574DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC20241008_e9f7f923-e7f9-4c52-b56d-914d800c1acf.zip
70121-1574DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]5Current NDC, Legacy NDC20241008_c4071146-7d89-4c3a-9278-389d801cf66d.zip
70121-1574DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, Legacy NDC20250102_01ca2f07-9c84-e418-e063-6294a90ac760.zip
70121-1574DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, Legacy NDC20250102_01ca7a2d-e8cb-c063-e063-6294a90ae7f9.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATESportpharm LLC62f4339a-a971-414d-b407-ef030fe4f9892026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210043
application number: ANDA210043
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals NY LLC8ea42650-21cd-49e4-92c8-48f2eeaf95bc2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210043
application number: ANDA210043
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLC3184a75e-61c5-4281-abf0-4eab861ca0092026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210043
application number: ANDA210043
Dyural 80 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAsclemed USA, Inc.e9f7f923-e7f9-4c52-b56d-914d800c1acf2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70121-1574-1
ndc11 (package): 70121157401
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLCd944240d-2c19-46ba-ad4f-3fbee7b8629c2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210043
application number: ANDA210043
ndc (package): 70121-1574-1
ndc (product): 70121-1574
ndc11 (package): 70121157401
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEA-S Medication Solutions1084208f-3b86-4aef-8247-5b6ed6cd50c72025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210043
application number: ANDA210043
Dyural 80-LMMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAdvanced Rx Pharmacy of Tennessee, LLC01ca7a2d-e8cb-c063-e063-6294a90ae7f92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70121-1574-1
ndc11 (package): 70121157401
Dyural 80 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAdvanced Rx Pharmacy of Tennessee, LLC01ca2f07-9c84-e418-e063-6294a90ac7602024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70121-1574-1
ndc11 (package): 70121157401
Dyural 80-LMMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.c4071146-7d89-4c3a-9278-389d801cf66d2024-10-05Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70121-1574-1
ndc11 (package): 70121157401
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEA-S Medication Solutions2f47d739-c39f-47c2-9e3c-1aef2cf201b12024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210043
application number: ANDA210043

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743779methylPREDNISolone acetate 40 MG in 1 ML InjectionPSNd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSNd944240d-2c19-46ba-ad4f-3fbee7b8629c16
17437791 ML methylprednisolone acetate 40 MG/ML InjectionSCDd944240d-2c19-46ba-ad4f-3fbee7b8629c16
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCDd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1743779methylprednisolone acetate 40 MG per 1 ML InjectionSYd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSYd944240d-2c19-46ba-ad4f-3fbee7b8629c16
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Medicated PadPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1737566lidocaine HCl 1 % in 5 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % Medicated PadPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807637sodium chloride 0.9 % in 10 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807638sodium chloride 0.9 % in 20 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807631sodium chloride 0.9 % in 50 ML InjectionPSNe9f7f923-e7f9-4c52-b56d-914d800c1acf11
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763710 ML sodium chloride 9 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763820 ML sodium chloride 9 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763150 ML sodium chloride 9 MG/ML InjectionSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 100 MG/ML Medicated PadSCDe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763710 ML NaCl 9 MG/ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763820 ML NaCl 9 MG/ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
180763150 ML NaCl 9 MG/ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Medicated PadSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Topical ClothSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797544isopropyl alcohol 70 % Topical SwabSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1737566lidocaine HCl 1 % per 5 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1737566lidocaine HCl 50 MG per 5 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807637normal saline 10 mL InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % Medicated PadSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
797730povidone-iodine 10 % Medicated SwabstickSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807637sodium chloride 0.9 % per 10 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807638sodium chloride 0.9 % per 20 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1807631sodium chloride 0.9 % per 50 ML InjectionSYe9f7f923-e7f9-4c52-b56d-914d800c1acf11
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN2f47d739-c39f-47c2-9e3c-1aef2cf201b18
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCD2f47d739-c39f-47c2-9e3c-1aef2cf201b18
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSY2f47d739-c39f-47c2-9e3c-1aef2cf201b18
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Medicated PadPSNc4071146-7d89-4c3a-9278-389d801cf66d5
1737566lidocaine HCl 1 % in 5 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSNc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % Medicated PadPSNc4071146-7d89-4c3a-9278-389d801cf66d5
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 100 MG/ML Medicated PadSCDc4071146-7d89-4c3a-9278-389d801cf66d5
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Medicated PadSYc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Topical ClothSYc4071146-7d89-4c3a-9278-389d801cf66d5
797544isopropyl alcohol 70 % Topical SwabSYc4071146-7d89-4c3a-9278-389d801cf66d5
1737566lidocaine HCl 1 % per 5 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
1737566lidocaine HCl 50 MG per 5 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSYc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % Medicated PadSYc4071146-7d89-4c3a-9278-389d801cf66d5
797730povidone-iodine 10 % Medicated SwabstickSYc4071146-7d89-4c3a-9278-389d801cf66d5
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
797544isopropyl alcohol 70 % Medicated PadPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
797544isopropyl alcohol 70 % Medicated PadPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1737566lidocaine HCl 1 % in 5 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
1737566lidocaine HCl 1 % in 5 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % Medicated PadPSN01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % Medicated PadPSN01ca7a2d-e8cb-c063-e063-6294a90ae7f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70121-1574-1701211574011 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE2019-05-200000-00-00NoNoCurrent