health mart loratadine

Product NDC
62011-0248
11-digit product format
620110248
Labeler code
62011
Product ID
62011-0248_df3bce77-ec2e-4d95-a815-513edb5966dc
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA076301
Marketing category
ANDA
Marketing start
2014-10-02
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0248DDiscontinued by firm2026-10-05
excluded packagepackage62011-024862011-0248-1DDiscontinued by firm2026-10-05
excluded packagepackage62011-024862011-0248-2DDiscontinued by firm2026-10-05
excluded packagepackage62011-024862011-0248-3DDiscontinued by firm2026-10-05
excluded packagepackage62011-024862011-0248-4DDiscontinued by firm2026-10-05
excluded packagepackage62011-024862011-0248-5DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 41 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0248-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0248-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0248-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0248-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0248-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0248-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0248-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0248-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0248-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0248-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0248-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0248-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0248-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0248-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0248-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0248-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0248-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0248-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0248-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0248-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0248-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0248-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0248-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0248-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0248-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0248-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0248-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0248-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0248-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0248-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0248-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0248-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0248-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0248-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0248-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0248-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0248-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0248-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62011-0248-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62011-0248-1557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076301-001LORATADINELORATADINE10MGTABLET / ORAL2004-06-25

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2584e616aacf4f…
2026-08-18 06:07:402026-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0248-1EA - Each62011-024824b02764-1819-4d07-a0e7-be1e6db6170312019-02-13
62011-0248-2EA - Each62011-024893bd1410-6ee7-4fc8-81e2-f17f2909119e12015-09-10
62011-0248-3EA - Each62011-024868d899f4-6dd5-4388-a4da-7953daf376a312019-02-13
62011-0248-4EA - Each62011-0248aea0f20b-5e59-4e5d-8fd4-a4e2aceffe2812019-02-13
62011-0248-5EA - Each62011-0248e36a454d-769b-4982-b27e-ad98b1fbfca812019-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNHEALTH MART LORATADINE (LORATADINE) TABLET [MCKESSON]1
LORATADINEACTIVE MOIETY7AJO3BO7QNHEALTH MART LORATADINE (LORATADINE) TABLET [MCKESSON]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHEALTH MART LORATADINE (LORATADINE) TABLET [MCKESSON]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEALTH MART LORATADINE (LORATADINE) TABLET [MCKESSON]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EHEALTH MART LORATADINE (LORATADINE) TABLET [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0248HEALTH MART LORATADINE (LORATADINE) TABLET [STRATEGIC SOURCING SERVICES LLC]10Legacy NDC20250104_69664ec4-ce52-4dd5-a9f5-56dd0a8e6ef5.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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Allergy ReliefLORATADINECardinal Health 110, LLC. dba Leader6f5134c6-ece6-4e35-a0c3-13e0dfa173fa2025-04-01WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
up and up allergy reliefLORATADINETarget Corporationc4ef0110-89c3-4ded-9a9a-75c0f794f8692025-03-28WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
TopCare Allergy Relief 24 hourLORATADINETopco Associates LLCa500aebf-a020-4da9-afdb-a699077cb8e12025-03-28WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.fc63689e-e449-ca8f-e053-6394a90a54a22025-02-05WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.54b37bcc-a8b0-0c17-e054-00144ff8d46c2025-01-09WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
foster and thrive allergy reliefLORATADINEStrategic Sourcing Services LLCaff1ab34-51b0-488c-931e-c95aad2265722024-12-11WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good neighbor pharmacy loratadineLORATADINEAmerisource Bergen9dda0f0b-fbab-47ee-8db8-95bd126fc61c2024-12-11WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
exchange select allergy reliefLORATADINEArmy & Air Force Exchange Serviceea5622d9-4e71-4a1f-9200-6b4cecac12152024-12-02WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEA-S Medication Solutions9cc3d50a-81ce-4c9d-9721-209169a332e02024-08-21WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
allergy reliefLORATADINEMeijer Distribution Inc9261a02b-db43-462f-9f06-fb5624070e202024-08-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEAphena Pharma Solutions - Tennessee, LLCa2c92766-df4e-4414-9c42-e18bcf9db6b42024-04-09WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEA-S Medication Solutionsc288d849-59c9-4883-aac4-bae54acee8ac2024-03-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
members mark allergy reliefLORATADINESam's West Inc95c2b45a-d0e5-467c-aad4-7bbb6c9a52042024-03-11WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEA-S Medication Solutions5fda4906-4133-4293-8b39-4ddcf8d398012024-02-04WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
kirkland signature allerclearLORATADINECostco Wholesale Company2074d52e-8c0a-4e69-bfb1-864ffc07e25f2024-01-17WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
equate allergy reliefLORATADINEWal-Mart Stores Incdd36dc43-a9b7-4cda-86e0-9283d996a60a2022-12-05WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
basic care allergy reliefLORATADINEAmazon.com Services LLCa4a7f024-972b-4a16-9cb8-28954c2a74c62022-10-18WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEProficient Rx LPe9b87f79-ebed-4677-8e50-00cb4282ee562022-04-01WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
welby all day allergy reliefLORATADINEAldi, Incefe2fa11-8115-4d33-bb32-8e2509839ef42021-06-22WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEAphena Pharma Solutions - Tennessee, LLC8ffe2faf-3253-4121-a069-6f46e319c6f02020-05-13WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0248-26201102480210 BLISTER PACK in 1 CARTON (62011-0248-2) > 1 TABLET in 1 BLISTER PACK10 blister pack2014-10-020000-00-00NoNoCurrent
62011-0248-3620110248031 BOTTLE in 1 CARTON (62011-0248-3) > 90 TABLET in 1 BOTTLE1 bottle2014-10-020000-00-00NoNoCurrent
62011-0248-4620110248041 BOTTLE in 1 CARTON (62011-0248-4) > 300 TABLET in 1 BOTTLE1 bottle2018-10-040000-00-00NoNoCurrent
62011-0248-5620110248051 BOTTLE in 1 CARTON (62011-0248-5) > 30 TABLET in 1 BOTTLE1 bottle2018-11-060000-00-00NoNoCurrent