Home NDC 64980-637 RANITIDINE
Product NDC 64980-637
11-digit product format 649800637
Labeler code 64980
Product ID 64980-637_b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RANITIDINE
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA211289
Marketing category ANDA
Marketing start 2025-12-06
Substance RANITIDINE HYDROCHLORIDE
Active strength 300 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211289-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 A211289-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base RANITIDINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RANITIDINE HYDROCHLORIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BK76465IHM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198191 Internal RxNorm lookup 198193 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 64980-637-03 RANITIDINE 30 in 1 BOTTLE TABLET 30 1
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 Sample Exclude flag Status 64980-637-03 64980063703 30 TABLET in 1 BOTTLE (64980-637-03) 30 tablet 2025-12-06 No No Current