Home NDC 67751-163 Handy Solutions 24 Hour Allergy
Product NDC 67751-163
11-digit product format 677510163
Labeler code 67751
Product ID 67751-163_f6f7b483-e260-2138-e053-6394a90ae319
Type HUMAN OTC DRUG
Nonproprietary name LORATADINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Navajo Manufacturing Company Inc.
Application ANDA076134
Marketing category ANDA
Marketing start 2016-09-22
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076134-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2003-08-18
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 · 42 observed 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 2026-08-18 06:07:40 2026-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Handy Solutions 24 Hour Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AJO3BO7QN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311372 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67751-163-01 Handy Solutions 24 Hour Allergy 1 in 1 CARTON TABLET, FILM COATED 1 3 67751-163-01 Handy Solutions 24 Hour Allergy 6 in 1 POUCH TABLET, FILM COATED 6 3 67751-163-02 Handy Solutions 24 Hour Allergy 1 in 1 CARTON TABLET, FILM COATED 1 3 67751-163-02 Handy Solutions 24 Hour Allergy 2 in 1 POUCH TABLET, FILM COATED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67751-163 HANDY SOLUTIONS 24 HOUR ALLERGY (LORATADINE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.] 3 Current NDC, Legacy NDC, 4 package rows 20230316_67263031-9095-48f2-8b34-e589b28a7416.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 2 · 25 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 67751-163-01 67751016301 1 POUCH in 1 CARTON (67751-163-01) / 6 TABLET, FILM COATED in 1 POUCH 1 pouch 2016-09-22 0000-00-00 No No Current 67751-163-02 67751016302 1 POUCH in 1 CARTON (67751-163-02) / 2 TABLET, FILM COATED in 1 POUCH 1 pouch 2016-09-22 0000-00-00 No No Current