methylprednisolone

Product NDC
68382-916
11-digit product format
683820916
Labeler code
68382
Product ID
68382-916_6cebff10-362f-41a7-8f66-3d9e878760fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206751
Marketing category
ANDA
Marketing start
2018-05-01
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206751-001METHYLPREDNISOLONEMETHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23
A206751-002METHYLPREDNISOLONEMETHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23
A206751-003METHYLPREDNISOLONEMETHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23
A206751-004METHYLPREDNISOLONEMETHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A206751-001AB
A206751-002AB
A206751-003AB
A206751-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206751-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206751-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206751-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4W7ZR7023Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197971Internal RxNorm lookup
197973Internal RxNorm lookup
259966Internal RxNorm lookup
328161Internal RxNorm lookup
762675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eaa9c932-c659-4ef6-bf5a-186545d87320Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-916-01methylprednisolone100 in 1 BOTTLETABLET1008
68382-916-05methylprednisolone500 in 1 BOTTLETABLET5008
68382-916-34methylprednisolone1 in 1 CARTONTABLET18
68382-916-34methylprednisolone21 in 1 BLISTER PACKTABLET218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-916-01EA - Each68382-916d22f8fdf-6765-4430-a8c2-7301968c77e512018-08-13
68382-916-34EA - Each68382-916ee14ea23-565f-4fb1-a1d4-06055925d41912018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-916METHYLPREDNISOLONE TABLET [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 4 package rows20240701_eaa9c932-c659-4ef6-bf5a-186545d87320.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
methylprednisoloneMETHYLPREDNISOLONEBluePoint Laboratories7092df48-4904-4047-9916-e585417a216f2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEA-S Medication Solutions646bb826-8d5a-4b03-adfb-ed45daa86d442026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEMajor Pharmaceuticals3885151c-963e-4d22-b5b4-58968503ad8c2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEZydus Pharmaceuticals USA Inc.eaa9c932-c659-4ef6-bf5a-186545d873202025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
ndc (product): 68382-916
MethylprednisoloneMETHYLPREDNISOLONEAdvanced Rx Pharmacy of Tennessee, LLCf19f6120-3c25-2a28-e053-2a95a90a86d52024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEZydus Lifesciences Limitedfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee2024-12-05Exact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEProficient Rx LP177fd649-4339-4bfd-bd12-7e8de302412b2023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKeaa9c932-c659-4ef6-bf5a-186545d873208
328161methylPREDNISolone 16 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
197971methylPREDNISolone 32 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
259966methylPREDNISolone 4 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNeaa9c932-c659-4ef6-bf5a-186545d873208
197973methylPREDNISolone 8 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
328161methylprednisolone 16 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
197971methylprednisolone 32 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
259966methylprednisolone 4 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
197973methylprednisolone 8 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYeaa9c932-c659-4ef6-bf5a-186545d873208
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylPREDNISolone 4 MG Oral TabletPSN646bb826-8d5a-4b03-adfb-ed45daa86d447
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylprednisolone 4 MG Oral TabletSCD646bb826-8d5a-4b03-adfb-ed45daa86d447
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylPREDNISolone 4 MG Oral TabletPSN3885151c-963e-4d22-b5b4-58968503ad8c5
259966methylprednisolone 4 MG Oral TabletSCD3885151c-963e-4d22-b5b4-58968503ad8c5
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKf19f6120-3c25-2a28-e053-2a95a90a86d53
259966methylPREDNISolone 4 MG Oral TabletPSNf19f6120-3c25-2a28-e053-2a95a90a86d53
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNf19f6120-3c25-2a28-e053-2a95a90a86d53
259966methylprednisolone 4 MG Oral TabletSCDf19f6120-3c25-2a28-e053-2a95a90a86d53
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYf19f6120-3c25-2a28-e053-2a95a90a86d53
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK177fd649-4339-4bfd-bd12-7e8de302412b1
259966methylPREDNISolone 4 MG Oral TabletPSNe08ff15a-a457-a71d-e053-2a95a90ae08c1
259966methylPREDNISolone 4 MG Oral TabletPSN177fd649-4339-4bfd-bd12-7e8de302412b1
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN177fd649-4339-4bfd-bd12-7e8de302412b1
259966methylprednisolone 4 MG Oral TabletSCDe08ff15a-a457-a71d-e053-2a95a90ae08c1
259966methylprednisolone 4 MG Oral TabletSCD177fd649-4339-4bfd-bd12-7e8de302412b1
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY177fd649-4339-4bfd-bd12-7e8de302412b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-916-0168382091601100 TABLET in 1 BOTTLE (68382-916-01) 100 tablet2018-05-010000-00-00NoNoCurrent
68382-916-0568382091605500 TABLET in 1 BOTTLE (68382-916-05) 500 tablet2018-05-010000-00-00NoNoCurrent
68382-916-34683820916341 BLISTER PACK in 1 CARTON (68382-916-34) / 21 TABLET in 1 BLISTER PACK1 blister pack2018-05-010000-00-00NoNoCurrent