Home NDC 51672-2073 Childrens Loratadine
Product NDC 51672-2073
11-digit product format 516722073
Labeler code 51672
Product ID 51672-2073_4ef454c5-7e60-4107-e063-6394a90a6f93
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form SOLUTION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076805
Marketing category ANDA
Marketing start 2004-08-20
Substance LORATADINE
Active strength 5 mg/5mL
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Childrens Loratadine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 5 mg/5mL
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 692783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-2073-4 Childrens Loratadine 60 mL in 1 BOTTLE SOLUTION 60 7 51672-2073-4 Childrens Loratadine 1 in 1 CARTON SOLUTION 1 7 51672-2073-5 Childrens Loratadine 180 mL in 1 BOTTLE SOLUTION 180 7 51672-2073-5 Childrens Loratadine 1 in 1 CARTON SOLUTION 1 7 51672-2073-8 Childrens Loratadine 120 mL in 1 BOTTLE SOLUTION 120 7 51672-2073-8 Childrens Loratadine 1 in 1 CARTON SOLUTION 1 7
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.] 2 Loratadine ACTIVE MOIETY 7AJO3BO7QN CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium metabisulfite INACTIVE INGREDIENT 4VON5FNS3C CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sucrose INACTIVE INGREDIENT C151H8M554 CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Loratadine ACTIVE INGREDIENT 7AJO3BO7QN LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 Loratadine ACTIVE INGREDIENT 7AJO3BO7QN LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 Loratadine ACTIVE MOIETY 7AJO3BO7QN LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 Loratadine ACTIVE MOIETY 7AJO3BO7QN LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 sodium metabisulfite INACTIVE INGREDIENT 4VON5FNS3C LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 sodium metabisulfite INACTIVE INGREDIENT 4VON5FNS3C LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 sucrose INACTIVE INGREDIENT C151H8M554 LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1 sucrose INACTIVE INGREDIENT C151H8M554 LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2073 CHILDRENS LORATADINE (LORATADINE) SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 6 package rows 20250519_78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0.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.
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 51672-2073-4 51672207304 1 BOTTLE in 1 CARTON (51672-2073-4) / 60 mL in 1 BOTTLE 1 bottle 2004-08-20 0000-00-00 No No Current 51672-2073-5 51672207305 1 BOTTLE in 1 CARTON (51672-2073-5) / 180 mL in 1 BOTTLE 1 bottle 2004-08-20 0000-00-00 No No Current 51672-2073-8 51672207308 1 BOTTLE in 1 CARTON (51672-2073-8) / 120 mL in 1 BOTTLE 1 bottle 2004-08-20 0000-00-00 No No Current