FDA.reportPublic FDA data

HYDROCORTISONE

Product NDC
71335-2770
11-digit product format
713352770
Labeler code
71335
Product ID
71335-2770_e07dd6d6-a1cc-49e0-8335-e483e3066ec0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214649
Marketing category
ANDA
Marketing start
2023-07-17
Substance
HYDROCORTISONE
Active strength
5 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui197787

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2770-1HYDROCORTISONE30 in 1 BOTTLETABLET301
71335-2770-2HYDROCORTISONE90 in 1 BOTTLETABLET901
71335-2770-3HYDROCORTISONE58 in 1 BOTTLETABLET581
71335-2770-4HYDROCORTISONE28 in 1 BOTTLETABLET281
71335-2770-5HYDROCORTISONE60 in 1 BOTTLETABLET601
71335-2770-6HYDROCORTISONE100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197787hydrocortisone 5 MG Oral TabletPSNdc220e63-f9b2-47ea-b8ed-940902a130bf1
197787hydrocortisone 5 MG Oral TabletSCDdc220e63-f9b2-47ea-b8ed-940902a130bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2770-17133527700130 TABLET in 1 BOTTLE (71335-2770-1) 30 tablet2025-10-03NoNoHistorical
71335-2770-27133527700290 TABLET in 1 BOTTLE (71335-2770-2) 90 tablet2025-10-03NoNoHistorical
71335-2770-37133527700358 TABLET in 1 BOTTLE (71335-2770-3) 58 tablet2025-10-03NoNoHistorical
71335-2770-47133527700428 TABLET in 1 BOTTLE (71335-2770-4) 28 tablet2025-10-03NoNoHistorical
71335-2770-57133527700560 TABLET in 1 BOTTLE (71335-2770-5) 60 tablet2025-10-03NoNoHistorical
71335-2770-671335277006100 TABLET in 1 BOTTLE (71335-2770-6) 100 tablet2025-10-03NoNoHistorical