Home NDC 63629-7669 Ranitidine
Product NDC 63629-7669
11-digit product format 636297669
Labeler code 63629
Product ID 63629-7669_32436bef-1898-4eb1-8a9b-ec560c24d855
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077824
Marketing category ANDA
Marketing start 2009-12-16
Marketing end 0000-00-00
Substance RANITIDINE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 108 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077824-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 A077824-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13
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 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2006-10-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB RS 2006-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-7669-1 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-2 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-3 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-4 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-5 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-6 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-7 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-8 2020-02-25 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-1 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-2 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-3 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-4 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-5 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-6 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-7 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only 63629-7669-8 2020-01-31 Ranitidine Tablets, USP (150 mg and 300 mg) Rx Only
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-7669-1 63629766901 20 TABLET in 1 BOTTLE (63629-7669-1) 20 tablet 2018-05-30 0000-00-00 No No Current 63629-7669-2 63629766902 30 TABLET in 1 BOTTLE (63629-7669-2) 30 tablet 2021-12-23 0000-00-00 No No Current 63629-7669-3 63629766903 60 TABLET in 1 BOTTLE (63629-7669-3) 60 tablet 2021-12-23 0000-00-00 No No Current 63629-7669-4 63629766904 90 TABLET in 1 BOTTLE (63629-7669-4) 90 tablet 2021-12-23 0000-00-00 No No Current 63629-7669-5 63629766905 300 TABLET in 1 BOTTLE (63629-7669-5) 300 tablet 2021-12-23 0000-00-00 No No Current 63629-7669-6 63629766906 500 TABLET in 1 BOTTLE (63629-7669-6) 500 tablet 2021-12-23 0000-00-00 No No Current 63629-7669-7 63629766907 800 TABLET in 1 BOTTLE (63629-7669-7) 800 tablet 2021-12-23 0000-00-00 No No Current 63629-7669-8 63629766908 1000 TABLET in 1 BOTTLE (63629-7669-8) 1000 tablet 2021-12-23 0000-00-00 No No Current