Hydrocortisone

Product NDC
64380-970
Requested package NDC
64380-970-25
11-digit product format
643800970
Labeler code
64380
Product ID
64380-970_e31ab65b-eef6-4d60-98fe-e2150a130b9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA207029
Marketing category
ANDA
Marketing start
2020-09-25
Substance
HYDROCORTISONE
Active strength
5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207029-001HYDROCORTISONEHYDROCORTISONE5MGTABLET / ORALAB2017-04-27
A207029-002HYDROCORTISONEHYDROCORTISONE10MGTABLET / ORALAB2017-04-27
A207029-003HYDROCORTISONEHYDROCORTISONE20MGTABLET / ORALAB2017-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207029-001AB
A207029-002AB
A207029-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207029-002HYDROCORTISONE10MGTABLET / ORALAB2017-04-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207029-003HYDROCORTISONE20MGTABLET / ORALAB2017-04-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207029-001HYDROCORTISONE5MGTABLET / ORALAB2017-04-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207029-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207029-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207029-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207029-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207029-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207029-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207029-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207029-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207029-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207029-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207029-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207029-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207029-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207029-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207029-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207029-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207029-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207029-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207029-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207029-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207029-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207029-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207029-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207029-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207029-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207029-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207029-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207029-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207029-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207029-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207029-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207029-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207029-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207029-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207029-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207029-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207029-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207029-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207029-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207029-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEStrides Pharma Science Limited90a46849-5b75-467b-9bc5-8f192d4d20d22026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207029
application number: ANDA207029
ndc (package): 64380-970-25
ndc (product): 64380-970
ndc11 (package): 64380097025
HydrocortisoneHYDROCORTISONEPD-Rx Pharmaceuticals, Inc.931ed426-89a1-4877-a4a5-cb963d51e7172026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207029
application number: ANDA207029
HydrocortisoneHYDROCORTISONEStrides Pharma Inc.c58dfac3-a131-4b6b-bf75-ba46e5bc6ba62026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207029
application number: ANDA207029
HydrocortisoneHYDROCORTISONEChartwell RX, LLC.4b6edbc4-7afb-4fb5-a16e-66ce70916f092025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207029
application number: ANDA207029
HydrocortisoneHYDROCORTISONEAmerican Health Packaging506aab0d-9308-4d60-90b3-7d64952fff362025-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207029
application number: ANDA207029
HydrocortisoneHYDROCORTISONEAsclemed USA, Inc.b8437441-a4a6-4fb5-82eb-e49af69704f42021-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207029
application number: ANDA207029

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocortisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197782Internal RxNorm lookup
197783Internal RxNorm lookup
197787Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
90a46849-5b75-467b-9bc5-8f192d4d20d2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-970-25Hydrocortisone50 in 1 BOTTLE, PLASTICTABLET5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-970HYDROCORTISONE TABLET [STRIDES PHARMA SCIENCE LIMITED]8Current NDC, Legacy NDC, 1 package rows20241205_90a46849-5b75-467b-9bc5-8f192d4d20d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197782hydrocortisone 10 MG Oral TabletPSN90a46849-5b75-467b-9bc5-8f192d4d20d210
197783hydrocortisone 20 MG Oral TabletPSN90a46849-5b75-467b-9bc5-8f192d4d20d210
197787hydrocortisone 5 MG Oral TabletPSN90a46849-5b75-467b-9bc5-8f192d4d20d210
197782hydrocortisone 10 MG Oral TabletSCD90a46849-5b75-467b-9bc5-8f192d4d20d210
197783hydrocortisone 20 MG Oral TabletSCD90a46849-5b75-467b-9bc5-8f192d4d20d210
197787hydrocortisone 5 MG Oral TabletSCD90a46849-5b75-467b-9bc5-8f192d4d20d210
197782hydrocortisone 10 MG Oral TabletPSN506aab0d-9308-4d60-90b3-7d64952fff366
197787hydrocortisone 5 MG Oral TabletPSN506aab0d-9308-4d60-90b3-7d64952fff366
197782hydrocortisone 10 MG Oral TabletSCD506aab0d-9308-4d60-90b3-7d64952fff366
197787hydrocortisone 5 MG Oral TabletSCD506aab0d-9308-4d60-90b3-7d64952fff366
197787hydrocortisone 5 MG Oral TabletPSNb8437441-a4a6-4fb5-82eb-e49af69704f41
197787hydrocortisone 5 MG Oral TabletSCDb8437441-a4a6-4fb5-82eb-e49af69704f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-970-256438009702550 TABLET in 1 BOTTLE, PLASTIC (64380-970-25) 50 tablet2020-09-250000-00-00NoNoCurrent