Home NDC 69728-0001 BICARUVAS
Product NDC 69728-0001
11-digit product format 697280001
Labeler code 69728
Product ID 69728-0001_11ac9e26-dd8c-5321-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name ANTACID
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler PROSANA DISTRIBUCIONES, S.A. DE C.V.
Application part331
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-04-23
Marketing end 0000-00-00
Substance TARTARIC ACID; CALCIUM CARBONATE; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE
Active strength 2 g/944mL; g/944mL; g/944mL; g/944mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69728-0001-2 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69728-0001-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69728-0001-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69728-0001-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69728-0001-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69728-0001-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69728-0001-2 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69728-0001-2 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69728-0001-2 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69728-0001-2 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69728-0001-2 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69728-0001-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69728-0001-2 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69728-0001-2 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69728-0001-2 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69728-0001-2 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69728-0001-2 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69728-0001-2 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 69728-0001-2 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69728-0001-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 69728-0001-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69728-0001-2 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 69728-0001-1 BICARUVAS 944 mL in 1 PACKET POWDER, FOR SOLUTION 944 4 69728-0001-2 BICARUVAS 8 in 1 BOX POWDER, FOR SOLUTION 8 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM CARBONATE ACTIVE INGREDIENT H0G9379FGK BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 CITRIC ACID MONOHYDRATE ACTIVE INGREDIENT 2968PHW8QP BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 TARTARIC ACID ACTIVE INGREDIENT W4888I119H BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 ANHYDROUS CITRIC ACID ACTIVE MOIETY XF417D3PSL BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 TARTARIC ACID ACTIVE MOIETY W4888I119H BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 GRAPE INACTIVE INGREDIENT 6X543N684K BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 STEVIA LEAF INACTIVE INGREDIENT 6TC6NN0876 BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69728-0001 BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.] 4 Legacy NDC, 2 package rows 20150702_19c65683-788e-6f71-e054-00144ff8d46c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 69728-0001-1 69728000101 944 mL in 1 PACKET 944 ml Historical 69728-0001-2 69728000102 8 in 1 BOX Historical