Texacort

Product NDC
0178-0455
11-digit product format
001780455
Labeler code
0178
Product ID
0178-0455_47e75db6-40d5-7014-e063-6294a90afcfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Mission Pharmacal Company
Application
ANDA081271
Marketing category
ANDA
Marketing start
2011-12-15
Substance
HYDROCORTISONE
Active strength
25 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A081271-001TEXACORTHYDROCORTISONE2.5%SOLUTION / TOPICALRS1992-04-17

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A081271-001TEXACORT2.5%SOLUTION / TOPICALRS1992-04-17cb3db0bc1861…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TexacortHYDROCORTISONEMission Pharmacal Company25279d46-6bad-471f-8bd6-736d53cfd9422026-01-08Adverse reactionsExact identifier
application applno (ANDA): 081271
application number: ANDA081271
ndc (product): 0178-0455
HydrocortisoneHYDROCORTISONETrifluent Pharma LLC20508a94-01bc-4f1d-a42b-122a31402aaf2025-12-01Adverse reactionsExact identifier
application applno (ANDA): 081271
application number: ANDA081271

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE25 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197786Internal RxNorm lookup
206336Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25279d46-6bad-471f-8bd6-736d53cfd942Available 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
0178-0455-01Texacort1 in 1 CARTONSOLUTION16
0178-0455-01Texacort30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0455-01ML - Milliliter0178-0455acaf961f-c505-4992-a136-3982023fddc912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0455TEXACORT (HYDROCORTISONE) SOLUTION [MISSION PHARMACAL COMPANY]5Current NDC, Legacy NDC, 2 package rows20240110_25279d46-6bad-471f-8bd6-736d53cfd942.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197786hydrocortisone 2.5 % Topical SolutionPSN25279d46-6bad-471f-8bd6-736d53cfd9426
206336Texacort 2.5 % Topical SolutionPSN25279d46-6bad-471f-8bd6-736d53cfd9426
206336hydrocortisone 25 MG/ML Topical Solution [Texacort]SBD25279d46-6bad-471f-8bd6-736d53cfd9426
197786hydrocortisone 25 MG/ML Topical SolutionSCD25279d46-6bad-471f-8bd6-736d53cfd9426
197786hydrocortisone 2.5 % Topical SolutionSY25279d46-6bad-471f-8bd6-736d53cfd9426
206336Texacort 2.5 % Topical SolutionSY25279d46-6bad-471f-8bd6-736d53cfd9426
206336Texacort 25 MG/ML Topical SolutionSY25279d46-6bad-471f-8bd6-736d53cfd9426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0455-01001780455011 BOTTLE, WITH APPLICATOR in 1 CARTON (0178-0455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR2011-12-150000-00-00NoNoCurrent