Application 078542

Type
ANDA
Sponsor
GLENMARK PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG BASENoNo
002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 300MG BASENoNo

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
A078542-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-19
A078542-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-19

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 06:07:402026-07A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A078542-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078542-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078542-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078542-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078542-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078542-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078542-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078542-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078542-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078542-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078542-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078542-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078542-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078542-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078542-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078542-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078542-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078542-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078542-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078542-002AB15aa47cf7b7d7…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ranitidine HydrochlorideRANITIDINE HYDROCHLORIDEDr. Reddy's Laboratories Limited7bf94bf7-fa11-70be-9f65-fe26a3db5a632018-11-21Adverse reactionsName fallback
brand name: Ranitidine Hydrochloride
generic name: RANITIDINE HYDROCHLORIDE
Acid ReducerRANITIDINE HYDROCHLORIDEWinCo Foods, LLC70bc7062-ab3c-43eb-b524-0d8c6d1a674d2014-12-10WarningsName fallback
generic name: RANITIDINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 82 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8021RanitidineRanitidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8021RanitidineRanitidineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-438RanitidineRanitidineBlenheim Pharmacal, Inc.ANDACurrent
49999-043RanitidineRanitidineQuality Care Products, LLCANDACurrent
49999-043RanitidineRanitidineQuality Care Products, LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1496RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-1496RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-1496RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-2574RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-2740RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-2740RanitidineRanitidineA-S Medication SolutionsANDACurrent
50436-6930RanitidineRanitidineUnit Dose ServicesANDACurrent
50436-6930RanitidineRanitidineUnit Dose ServicesANDACurrent
50436-6942RanitidineRanitidineUnit Dose ServicesANDACurrent
50436-6942RanitidineRanitidineUnit Dose ServicesANDACurrent
53002-5520RanitidineRanitidineRPK Pharmaceuticals, Inc.ANDACurrent
53217-372RanitidineRanitidineAidarex Pharmaceuticals LLCANDACurrent
60760-025RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
60760-025RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
60760-249RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
60760-249RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
61919-339RANITIDINERANITIDINEDIRECT RXANDACurrent
61919-339RANITIDINERANITIDINEDirect_RxANDACurrent
61919-339RANITIDINERANITIDINEDirect_RxANDACurrent
61919-455RANITIDINERANITIDINEDIRECT RXANDACurrent
61919-455RANITIDINERANITIDINEDirect_RxANDACurrent
61919-455RANITIDINERANITIDINEDirect_RxANDACurrent
63187-091RanitidineRanitidineProficient Rx LPANDACurrent
63187-091RanitidineRanitidineProficient Rx LPANDACurrent
63187-159RanitidineRanitidineProficient Rx LPANDACurrent
63187-159RanitidineRanitidineProficient Rx LPANDACurrent
63629-8216RanitidineRanitidineBryant Ranch PrepackANDACurrent
66267-188RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-188RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-452RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-452RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-734RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-734RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-815RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-815RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
67046-648RanitidineRanitidineContract Pharmacy Services-PAANDACurrent
67046-649RanitidineRanitidineContract Pharmacy Services-PAANDACurrent
68071-2185RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2185RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3162RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3162RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3165RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3248RanitidineRanitidineNuCarePharmaceuticals, Inc.ANDACurrent
68071-3248RanitidineRanitidineNuCarePharmaceuticals, Inc.ANDACurrent
68071-3317RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-5015RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5015RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68462-248RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-248RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-249RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-249RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6382RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6382RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7388RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7388RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7388RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
70518-0801RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-0801RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-1361RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-1361RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-287RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0342RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-0342RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-0363RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-0363RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-1327RanitidineRanitidineBryant Ranch PrepackANDACurrent