Home NDC 68016-352 Ranitidine - Acid Reducer
Product NDC 68016-352
11-digit product format 680160352
Labeler code 68016
Product ID 68016-352_f48d12b3-6601-461a-97f0-6b233e5ac724
Type HUMAN OTC DRUG
Nonproprietary name Ranitidine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chain Drug Consortium, LLC.
Application ANDA201745
Marketing category ANDA
Marketing start 2012-07-10
Marketing end 0000-00-00
Substance RANITIDINE HYDROCHLORIDE
Active strength 75 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
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 · 63 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201745-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29
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 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201745-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2012-02-29 e64feba35796…
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 68016-352-30 Ranitidine - Acid Reducer 30 in 1 BOTTLE TABLET, FILM COATED 30 2 68016-352-60 Ranitidine - Acid Reducer 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-352 RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.] 2 Legacy NDC, 2 package rows 20151014_92e1e60c-be24-4b20-8a2a-a39d03cc3cf3.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 68016-352-30 68016035230 30 in 1 BOTTLE Historical 68016-352-60 68016035260 60 in 1 BOTTLE Historical