Home NDC 71821-002 Ranitidine
Product NDC 71821-002
11-digit product format 718210002
Labeler code 71821
Product ID 71821-002_b9878674-e349-4222-8dee-b026f4f0c5b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler VKT Pharma Private Limited
Application ANDA211289
Marketing category ANDA
Marketing start 2019-02-18
Marketing end 0000-00-00
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 2020-12-31
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 1 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71821-002-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71821-002-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71821-002-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71821-002-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71821-002-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71821-002-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71821-002-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71821-002-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71821-002-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71821-002-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71821-002-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71821-002-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 71821-002-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71821-002-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71821-002-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 71821-002-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 71821-002-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 71821-002-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 71821-002-01 8dfbde2a14a4…c9ff85d89658…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 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…2021-12-28 21:50 UTC 2021-12 A211289-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211289-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2019-01-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71821-002-01 Ranitidine 250 in 1 CONTAINER TABLET, FILM COATED 250 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71821-002 RANITIDINE TABLET, FILM COATED [VKT PHARMA PRIVATE LIMITED] 1 Legacy NDC, 1 package rows 20190220_a9f506bf-21ef-4323-9ce8-e8a7b561c496.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 Status 71821-002-01 71821000201 250 in 1 CONTAINER Historical