FDA.reportPublic FDA data

Loratadine

Product NDC
59556-882
11-digit product format
595560882
Labeler code
59556
Product ID
59556-882_0d278505-f077-4d6e-885c-d1dc624e84e2
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA211926
Marketing category
ANDA
Marketing start
2021-06-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59556-882DDiscontinued by firm2026-08-17
excluded packagepackage59556-88259556-882-01DDiscontinued by firm2026-08-17
excluded packagepackage59556-88259556-882-81DDiscontinued by firm2026-08-17

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 · 6 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 packagepackage59556-882-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59556-882-81d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59556-882-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59556-882-81f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211926-001LORATADINELORATADINE10MGCAPSULE / ORAL2020-01-15

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211926-001LORATADINE10MGCAPSULE / ORAL2020-01-15a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59556-882-01595560882011 BLISTER PACK in 1 CARTON (59556-882-01) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2021-06-010000-00-00NoNoCurrent
59556-882-81595560882813 BLISTER PACK in 1 CARTON (59556-882-81) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2021-06-010000-00-00NoNoCurrent