FDA.reportPublic FDA data

Alkindi

Product NDC
71863-110
11-digit product format
718630110
Labeler code
71863
Product ID
71863-110_4ffdccff-95d3-7c88-e063-6394a90a1c9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
GRANULE
Route
ORAL
Labeler
Eton Pharmaceuticals, Inc.
Application
NDA213876
Marketing category
NDA
Marketing start
2020-09-29
Substance
HYDROCORTISONE
Active strength
1 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 42.

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
N213876-001ALKINDI SPRINKLEHYDROCORTISONE0.5MGGRANULE / ORALRLD2020-09-29
N213876-002ALKINDI SPRINKLEHYDROCORTISONE1MGGRANULE / ORALRLD2020-09-29
N213876-003ALKINDI SPRINKLEHYDROCORTISONE2MGGRANULE / ORALRLD2020-09-29
N213876-004ALKINDI SPRINKLEHYDROCORTISONE5MGGRANULE / ORALRLD, RS2020-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213876-00197177402032-11-19U-30752021-03-03
N213876-00196755592033-01-10U-30752021-03-03
N213876-00196492802034-05-12U-3075Drug product2021-03-03
N213876-00297177402032-11-19U-30752021-03-03
N213876-00296755592033-01-10U-30752021-03-03
N213876-00296492802034-05-12U-3075Drug product2021-03-03
N213876-00397177402032-11-19U-30752021-03-03
N213876-00396755592033-01-10U-30752021-03-03
N213876-00396492802034-05-12U-3075Drug product2021-03-03
N213876-00497177402032-11-19U-30752021-03-03
N213876-00496755592033-01-10U-30752021-03-03
N213876-00496492802034-05-12U-3075Drug product2021-03-03

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 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213876-001ALKINDI SPRINKLE0.5MGGRANULE / ORALRLD2020-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213876-002ALKINDI SPRINKLE1MGGRANULE / ORALRLD2020-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213876-003ALKINDI SPRINKLE2MGGRANULE / ORALRLD2020-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213876-004ALKINDI SPRINKLE5MGGRANULE / ORALRLD, RS2020-09-29d8e5a09893c0…

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N213876-00197177402032-11-19U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00196755592033-01-10U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00196492802034-05-12U-3075Drug product2021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00297177402032-11-19U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00296755592033-01-10U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00296492802034-05-12U-3075Drug product2021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00397177402032-11-19U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00396755592033-01-10U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00396492802034-05-12U-3075Drug product2021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00497177402032-11-19U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00496755592033-01-10U-30752021-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213876-00496492802034-05-12U-3075Drug product2021-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213876-00197177402032-11-19U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00196755592033-01-10U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00196492802034-05-12U-3075Drug product2021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00297177402032-11-19U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00296755592033-01-10U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00296492802034-05-12U-3075Drug product2021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00397177402032-11-19U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00396755592033-01-10U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00396492802034-05-12U-3075Drug product2021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00497177402032-11-19U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00496755592033-01-10U-30752021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213876-00496492802034-05-12U-3075Drug product2021-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00197177402032-11-19U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00196755592033-01-10U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00196492802034-05-12U-3075Drug product2021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00297177402032-11-19U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00296755592033-01-10U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00296492802034-05-12U-3075Drug product2021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00397177402032-11-19U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00396755592033-01-10U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00396492802034-05-12U-3075Drug product2021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00497177402032-11-19U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00496755592033-01-10U-30752021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213876-00496492802034-05-12U-3075Drug product2021-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N213876-00197177402032-11-19U-30752021-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213876-00196755592033-01-10U-30752021-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213876-00196492802034-05-12U-3075Drug product2021-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213876-00297177402032-11-19U-30752021-03-036a471c1ec25d…

Additional Listing Data#

Finished product
Yes
Brand name base
Alkindi
Brand name suffix
Sprinkle
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2399644Internal RxNorm lookup
2399650Internal RxNorm lookup
2399652Internal RxNorm lookup
2399654Internal RxNorm lookup
2399656Internal RxNorm lookup
2399658Internal RxNorm lookup
2399659Internal RxNorm lookup
2399661Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26c13a5f-7119-4c6a-bf10-fda4e07d7682Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71863-110-50Alkindi Sprinkle50 in 1 BOTTLE, PLASTICGRANULE5020
71863-110-50Alkindi Sprinkle1 in 1 CARTONGRANULE120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71863-110ALKINDI SPRINKLE (HYDROCORTISONE) GRANULE ALKINDI SPRINKLE (HYDROCORTISONE) GRANULE [ETON PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 2 package rows20250201_26c13a5f-7119-4c6a-bf10-fda4e07d7682.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
Alkindi SprinkleHYDROCORTISONEEton Pharmaceuticals, Inc.26c13a5f-7119-4c6a-bf10-fda4e07d76822026-04-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 213876
application number: NDA213876
ndc (product): 71863-110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2399650Alkindi Sprinkle 0.5 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399654Alkindi Sprinkle 1 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399658Alkindi Sprinkle 2 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399661Alkindi Sprinkle 5 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399644hydrocortisone 0.5 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399652hydrocortisone 1 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399656hydrocortisone 2 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399659hydrocortisone 5 MG Oral GranulesPSN26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399650hydrocortisone 0.5 MG Oral Granules [Alkindi]SBD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399654hydrocortisone 1 MG Oral Granules [Alkindi]SBD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399658hydrocortisone 2 MG Oral Granules [Alkindi]SBD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399661hydrocortisone 5 MG Oral Granules [Alkindi]SBD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399644hydrocortisone 0.5 MG Oral GranulesSCD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399652hydrocortisone 1 MG Oral GranulesSCD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399656hydrocortisone 2 MG Oral GranulesSCD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399659hydrocortisone 5 MG Oral GranulesSCD26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399650Alkindi 0.5 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399654Alkindi 1 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399658Alkindi 2 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399661Alkindi 5 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399650Alkindi Sprinkle 0.5 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399654Alkindi Sprinkle 1 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399658Alkindi Sprinkle 2 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220
2399661Alkindi Sprinkle 5 MG Oral GranulesSY26c13a5f-7119-4c6a-bf10-fda4e07d768220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71863-110-50718630110501 BOTTLE, PLASTIC in 1 CARTON (71863-110-50) / 50 GRANULE in 1 BOTTLE, PLASTIC2020-09-290000-00-00NoNoCurrent