Maximum Strength Zantac

Product NDC
0597-0121
11-digit product format
005970121
Labeler code
0597
Product ID
0597-0121_97c9418c-db80-a529-e053-2a95a90aab9a
Type
HUMAN OTC DRUG
Nonproprietary name
ranitidine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals Inc.
Application
NDA021698
Marketing category
NDA
Marketing start
2006-12-21
Marketing end
2021-11-30
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 18 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0597-0121DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-01DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-06DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-08DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-09DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-11DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-24DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-38DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-50DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-64DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-66DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-68DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-78DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-80DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-82DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-85DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-90DDiscontinued by firm2026-08-17
excluded packagepackage0597-01210597-0121-94DDiscontinued by firm2026-08-17

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 4 · 216 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-68d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-82d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-38d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0121-66d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-68f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-82f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-38f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0121-66f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-682ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-822ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-642ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-382ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-782ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0121-662ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0121-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0121-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0121-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0121-68a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0121-94a1b67e2a42f9…c4cf2c586c0d…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021698-001ZANTAC 150RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALRLD2004-08-31
N021698-002ZANTAC 150RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALRLD2007-03-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD, RS2004-08-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021698-001ZANTAC 150EQ 150MG BASETABLET / ORALRLD2004-08-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021698-002ZANTAC 150EQ 150MG BASETABLET / ORALRLD2007-03-13bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0121-24EA - Each0597-0121f5302b60-3cb0-4798-945e-392de372d73612012-07-24
0597-0121-50EA - Each0597-012152fe690d-3c38-4b1f-8236-f13a7248401d12012-07-24
0597-0121-68EA - Each0597-01218b633da4-67ec-4fdf-9e51-981627caa05112012-07-24
0597-0121-90EA - Each0597-0121bdb0cd21-0472-4295-ae3f-73af5ddcb28712012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0121-01005970121012 BOTTLE in 1 CARTON (0597-0121-01) > 50 TABLET, COATED in 1 BOTTLE2 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-06005970121061 BLISTER PACK in 1 CARTON (0597-0121-06) > 3 TABLET, COATED in 1 BLISTER PACK1 blister pack2006-12-212021-11-30NoNoCurrent
0597-0121-08005970121081 TABLET, COATED in 1 POUCH (0597-0121-08) 2006-12-212021-11-30NoNoCurrent
0597-0121-09005970121094 BLISTER PACK in 1 CARTON (0597-0121-09) > 8 TABLET, COATED in 1 BLISTER PACK4 blister pack2006-12-212021-11-30NoNoCurrent
0597-0121-11005970121112 BOTTLE in 1 CARTON (0597-0121-11) > 60 TABLET, COATED in 1 BOTTLE2 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-24005970121243 BLISTER PACK in 1 CARTON (0597-0121-24) > 8 TABLET, COATED in 1 BLISTER PACK3 blister pack2006-12-212021-11-30NoNoCurrent
0597-0121-38005970121381 BLISTER PACK in 1 CARTON (0597-0121-38) > 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2006-12-212021-11-30NoNoCurrent
0597-0121-50005970121501 BOTTLE in 1 CARTON (0597-0121-50) > 50 TABLET, COATED in 1 BOTTLE1 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-64005970121641 BOTTLE in 1 CARTON (0597-0121-64) > 65 TABLET, COATED in 1 BOTTLE1 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-66005970121661 BOTTLE in 1 CARTON (0597-0121-66) > 40 TABLET, COATED in 1 BOTTLE1 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-68005970121681 BOTTLE in 1 CARTON (0597-0121-68) > 65 TABLET, COATED in 1 BOTTLE1 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-78005970121781 BOTTLE in 1 CARTON (0597-0121-78) > 78 TABLET, COATED in 1 BOTTLE1 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-800059701218080 POUCH in 1 CARTON (0597-0121-80) > 1 TABLET, COATED in 1 POUCH80 pouch2006-12-212021-11-30NoNoCurrent
0597-0121-820059701218280 POUCH in 1 CARTON (0597-0121-82) > 1 TABLET, COATED in 1 POUCH80 pouch2006-12-212021-11-30NoNoCurrent
0597-0121-85005970121851 BOTTLE in 1 CARTON (0597-0121-85) > 85 TABLET, COATED in 1 BOTTLE1 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-90005970121902 BOTTLE in 1 CARTON (0597-0121-90) > 45 TABLET, COATED in 1 BOTTLE2 bottle2006-12-212021-11-30NoNoCurrent
0597-0121-94005970121941 BOTTLE in 1 CARTON (0597-0121-94) > 45 TABLET, COATED in 1 BOTTLE1 bottle2006-12-212021-11-30NoNoCurrent