Home NDC 51672-2092 Childrens Loratadine
Product NDC 51672-2092
11-digit product format 516722092
Labeler code 51672
Product ID 51672-2092_a032a1a9-e0ce-4176-8479-75263c601d65
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form SOLUTION
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA076805
Marketing category ANDA
Marketing start 2010-02-27
Marketing end 0000-00-00
Substance LORATADINE
Active strength 5 mg/5mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076805-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 cb3db0bc1861…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Loratadine ACTIVE INGREDIENT 7AJO3BO7QN CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 Loratadine ACTIVE MOIETY 7AJO3BO7QN CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 phosphoric acid INACTIVE INGREDIENT E4GA8884NN CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium metabisulfite INACTIVE INGREDIENT 4VON5FNS3C CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium phosphate, monobasic, dihydrate INACTIVE INGREDIENT 5QWK665956 CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 sorbitol INACTIVE INGREDIENT 506T60A25R CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2092 CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Legacy NDC 20241222_c4d05a9a-3765-4144-803e-462712bf3772.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 1 · 15 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-2092-1 51672209201 1 BOTTLE in 1 CARTON (51672-2092-1) > 240 mL in 1 BOTTLE 1 bottle 2010-02-27 0000-00-00 No No Current 51672-2092-4 51672209204 1 BOTTLE in 1 CARTON (51672-2092-4) > 60 mL in 1 BOTTLE 1 bottle 2010-02-27 0000-00-00 No No Current 51672-2092-8 51672209208 1 BOTTLE in 1 CARTON (51672-2092-8) > 120 mL in 1 BOTTLE 1 bottle 2010-02-27 0000-00-00 No No Current