Home NDC 70010-162 Loratadine
Product NDC 70010-162
11-digit product format 700100162
Labeler code 70010
Product ID 70010-162_5d4edf49-1b98-a625-e063-6394a90ab9c5
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Granules Pharmaceuticals Inc.
Application ANDA210722
Marketing category ANDA
Marketing start 2020-01-01
Substance LORATADINE
Active strength 10 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210722-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2019-12-23
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Loratadine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 10 mg/1
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70010-162-01 Loratadine 100 in 1 BOTTLE TABLET 100 5 70010-162-03 Loratadine 30 in 1 BOTTLE TABLET 30 5 70010-162-34 Loratadine 300 in 1 BOTTLE TABLET 300 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70010-162 LORATADINE TABLET [GRANULES PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 3 package rows 20250508_d15add22-bc2d-9730-e053-2a95a90acd3f.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 2 · 37 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70010-162-01 70010016201 100 TABLET in 1 BOTTLE (70010-162-01) 100 tablet 2021-11-17 0000-00-00 No No Current 70010-162-03 70010016203 30 TABLET in 1 BOTTLE (70010-162-03) 30 tablet 2022-05-01 No No Current 70010-162-34 70010016234 300 TABLET in 1 BOTTLE (70010-162-34) 300 tablet 2022-05-01 0000-00-00 No No Current