Home NDC 0121-4727-10 Ranitidine
Product NDC 0121-4727
Requested package NDC 0121-4727-10
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 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 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 · 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 cb3db0bc1861…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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