Home NDC 0121-4727 Ranitidine
Product NDC 0121-4727
11-digit product format 001214727
Labeler code 0121
Product ID 0121-4727_d56a22ea-5dab-e98a-e053-2a95a90a34c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RANITIDINE
Dosage form SYRUP
Route ORAL
Labeler Pharmaceutical Associates, Inc.
Application ANDA077405
Marketing category ANDA
Marketing start 2010-11-01
Substance RANITIDINE
Active strength 15 mg/mL
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
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 A077405-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21
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 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ranitidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RANITIDINE 15 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884KT10YB7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 705610 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-4727-10 Ranitidine 10 in 1 TRAY SYRUP 10 8 0121-4727-10 Ranitidine 4 in 1 CASE SYRUP 4 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-4727 RANITIDINE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20220113_d0da9dd6-c691-4614-99c7-531b0bf34837.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 · 1 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 0121-4727-10 00121472710 4 TRAY in 1 CASE (0121-4727-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE 4 tray 2010-11-01 0000-00-00 No No Current