Ranitidine

Product NDC
53746-253
11-digit product format
537460253
Labeler code
53746
Product ID
53746-253_906b462d-e4a3-4f23-8d1b-2605476c40e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A077824-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13
A077824-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13

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 06:07:402026-07A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13caaa826d4ba7…
2026-08-18 06:07:402026-07A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2006-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALABRS2006-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077824-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077824-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077824-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077824-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077824-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077824-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077824-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077824-002AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Ranitidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BK76465IHMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198191Internal RxNorm lookup
198193Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b38a3332-5c54-453f-aeb7-070f830955c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-253-01Ranitidine100 in 1 BOTTLETABLET10021
53746-253-05Ranitidine500 in 1 BOTTLETABLET50021
53746-253-10Ranitidine1000 in 1 BOTTLETABLET100021
53746-253-18Ranitidine180 in 1 BOTTLETABLET18021
53746-253-60Ranitidine60 in 1 BOTTLETABLET6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-253-01EA - Each53746-25363547cea-15e7-4b5e-9bcd-0c0feb5e38ef12012-07-24
53746-253-05EA - Each53746-253eda54e26-eac3-4a49-8272-3c9e6ce3f08812012-07-24
53746-253-10EA - Each53746-253c3c0480e-02af-4783-a6af-9b87cf77b70612012-07-24
53746-253-18EA - Each53746-253cef531ac-dfb8-4db4-b0b2-ba925f7b115912012-07-24
53746-253-60EA - Each53746-253da9fb701-ca19-494d-b12b-068b1a75a79412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMGABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
CHOLINEACTIVE MOIETYN91BDP6H0XGABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
RANITIDINEACTIVE MOIETY884KT10YB7GABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
GELATININACTIVE INGREDIENT2G86QN327LGABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABITIDINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]17
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMSENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE MOIETYN91BDP6H0XSENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
RANITIDINEACTIVE MOIETY884KT10YB7SENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
GELATININACTIVE INGREDIENT2G86QN327LSENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENTRADINE (RANITIDINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE (RANITIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [AVKARE, INC.]3
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [AVKARE, INC.]3
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [AVKARE, INC.]3
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [AVKARE, INC.]3
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GRANITIDINE TABLET [AVKARE, INC.]3
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE TABLET [AVKARE, INC.]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [AVKARE, INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [AVKARE, INC.]3
PolydextroseINACTIVE INGREDIENTVH2XOU12IERANITIDINE TABLET [AVKARE, INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [AVKARE, INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [AVKARE, INC.]3
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE TABLET [AVKARE, INC.]3
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [STAT RX USA LLC]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [BRYANT RANCH PREPACK]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [CARILION MATERIALS MANAGEMENT]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [RXCHANGE CO.]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [STAT RX USA LLC]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [BRYANT RANCH PREPACK]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [CARILION MATERIALS MANAGEMENT]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [RXCHANGE CO.]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [BRYANT RANCH PREPACK]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [BRYANT RANCH PREPACK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [STAT RX USA LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [BRYANT RANCH PREPACK]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE TABLET [BRYANT RANCH PREPACK]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE TABLET [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [BRYANT RANCH PREPACK]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERANITIDINE TABLET [STAT RX USA LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERANITIDINE TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [BRYANT RANCH PREPACK]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE TABLET [STAT RX USA LLC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE TABLET [BRYANT RANCH PREPACK]2
CAPSICUM OLEORESINACTIVE INGREDIENTUW86K581WYDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CAPSICUM OLEORESINACTIVE MOIETYUW86K581WYDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
DICLOFENACACTIVE MOIETY144O8QL0L1DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-253RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]19Current NDC, Legacy NDC, 5 package rows20230112_b38a3332-5c54-453f-aeb7-070f830955c2.zip
53746-253DERAMSILKRX ANODYNEXA PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1Current NDC, Legacy NDC20150720_1b49b08b-8494-3f71-e054-00144ff88e88.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RanitidineRANITIDINEAmneal Pharmaceuticals of New York LLCb38a3332-5c54-453f-aeb7-070f830955c22026-05-01Adverse reactionsExact identifier
application applno (ANDA): 077824
application number: ANDA077824
ndc (product): 53746-253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNb38a3332-5c54-453f-aeb7-070f830955c221
198193ranitidine 300 MG Oral TabletPSNb38a3332-5c54-453f-aeb7-070f830955c221
198191ranitidine 150 MG Oral TabletSCDb38a3332-5c54-453f-aeb7-070f830955c221
198193ranitidine 300 MG Oral TabletSCDb38a3332-5c54-453f-aeb7-070f830955c221
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYb38a3332-5c54-453f-aeb7-070f830955c221
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYb38a3332-5c54-453f-aeb7-070f830955c221
198191ranitidine 150 MG Oral TabletPSNf0a096a0-bde2-494f-a1af-2f778bb7c5c117
198191ranitidine 150 MG Oral TabletSCDf0a096a0-bde2-494f-a1af-2f778bb7c5c117
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYf0a096a0-bde2-494f-a1af-2f778bb7c5c117
198191ranitidine 150 MG Oral TabletPSNd267425d-4e5f-4e7a-a27e-fe8814f0e2259
198191ranitidine 150 MG Oral TabletSCDd267425d-4e5f-4e7a-a27e-fe8814f0e2259
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYd267425d-4e5f-4e7a-a27e-fe8814f0e2259
198191ranitidine 150 MG Oral TabletPSN9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG Oral TabletPSN9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG Oral TabletSCD9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG Oral TabletSCD9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG Oral TabletPSN8b65ebf4-e1a7-4592-8652-93dc5e0114373
198191ranitidine 150 MG Oral TabletPSNa0a40104-2196-4ea2-9577-63b86d6acb653
198193ranitidine 300 MG Oral TabletPSNa0a40104-2196-4ea2-9577-63b86d6acb653
198191ranitidine 150 MG Oral TabletSCD8b65ebf4-e1a7-4592-8652-93dc5e0114373
198191ranitidine 150 MG Oral TabletSCDa0a40104-2196-4ea2-9577-63b86d6acb653
198193ranitidine 300 MG Oral TabletSCDa0a40104-2196-4ea2-9577-63b86d6acb653
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY8b65ebf4-e1a7-4592-8652-93dc5e0114373
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYa0a40104-2196-4ea2-9577-63b86d6acb653
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYa0a40104-2196-4ea2-9577-63b86d6acb653
198191ranitidine 150 MG Oral TabletPSN5b9620b9-1660-4b35-b700-6b1347ed9ecb2
198191ranitidine 150 MG Oral TabletPSN1d733324-93c6-201c-e054-00144ff88e882
198191ranitidine 150 MG Oral TabletPSNd5962f4c-1cbc-4034-b171-9a35fc75b5462
198191ranitidine 150 MG Oral TabletPSN2b5da879-5380-476e-99d6-2a25f8bb2ee92
198193ranitidine 300 MG Oral TabletPSNd5962f4c-1cbc-4034-b171-9a35fc75b5462
198191ranitidine 150 MG Oral TabletSCD2b5da879-5380-476e-99d6-2a25f8bb2ee92
198191ranitidine 150 MG Oral TabletSCD1d733324-93c6-201c-e054-00144ff88e882
198191ranitidine 150 MG Oral TabletSCDd5962f4c-1cbc-4034-b171-9a35fc75b5462
198191ranitidine 150 MG Oral TabletSCD5b9620b9-1660-4b35-b700-6b1347ed9ecb2
198193ranitidine 300 MG Oral TabletSCDd5962f4c-1cbc-4034-b171-9a35fc75b5462
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY5b9620b9-1660-4b35-b700-6b1347ed9ecb2
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY2b5da879-5380-476e-99d6-2a25f8bb2ee92
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYd5962f4c-1cbc-4034-b171-9a35fc75b5462
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY1d733324-93c6-201c-e054-00144ff88e882
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYd5962f4c-1cbc-4034-b171-9a35fc75b5462
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN1b49b08b-8494-3f71-e054-00144ff88e881
198191ranitidine 150 MG Oral TabletPSN11f47301-cec7-1516-e054-00144ff88e881
198191ranitidine 150 MG Oral TabletPSN11befb08-9e40-7500-e054-00144ff8d46c1
198191ranitidine 150 MG Oral TabletPSNf19c60c8-e1f3-4d1f-80d3-833e67f333391
198191ranitidine 150 MG Oral TabletPSNb85c7258-f5a2-4baa-b2e5-f951da7589e91
198191ranitidine 150 MG Oral TabletPSN1b49b08b-8494-3f71-e054-00144ff88e881
198191ranitidine 150 MG Oral TabletPSNae8c3e95-3503-4553-bc58-cc3e0170bcf81
198191ranitidine 150 MG Oral TabletPSNa9fef8f6-b823-4b8a-84b8-2b916374adb51
198193ranitidine 300 MG Oral TabletPSNa9fef8f6-b823-4b8a-84b8-2b916374adb51
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD1b49b08b-8494-3f71-e054-00144ff88e881
198191ranitidine 150 MG Oral TabletSCDf19c60c8-e1f3-4d1f-80d3-833e67f333391
198191ranitidine 150 MG Oral TabletSCDb85c7258-f5a2-4baa-b2e5-f951da7589e91
198191ranitidine 150 MG Oral TabletSCDae8c3e95-3503-4553-bc58-cc3e0170bcf81
198191ranitidine 150 MG Oral TabletSCDa9fef8f6-b823-4b8a-84b8-2b916374adb51
198191ranitidine 150 MG Oral TabletSCD1b49b08b-8494-3f71-e054-00144ff88e881
198191ranitidine 150 MG Oral TabletSCD11f47301-cec7-1516-e054-00144ff88e881
198191ranitidine 150 MG Oral TabletSCD11befb08-9e40-7500-e054-00144ff8d46c1
198193ranitidine 300 MG Oral TabletSCDa9fef8f6-b823-4b8a-84b8-2b916374adb51
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYb85c7258-f5a2-4baa-b2e5-f951da7589e91
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYae8c3e95-3503-4553-bc58-cc3e0170bcf81
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYa9fef8f6-b823-4b8a-84b8-2b916374adb51
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY1b49b08b-8494-3f71-e054-00144ff88e881
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY11f47301-cec7-1516-e054-00144ff88e881
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY11befb08-9e40-7500-e054-00144ff8d46c1
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYf19c60c8-e1f3-4d1f-80d3-833e67f333391
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYa9fef8f6-b823-4b8a-84b8-2b916374adb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-253-0153746025301100 TABLET in 1 BOTTLE (53746-253-01) 100 tablet2009-12-160000-00-00NoNoCurrent
53746-253-0553746025305500 TABLET in 1 BOTTLE (53746-253-05) 500 tablet2009-12-160000-00-00NoNoCurrent
53746-253-10537460253101000 TABLET in 1 BOTTLE (53746-253-10) 1000 tablet2009-12-160000-00-00NoNoCurrent
53746-253-1853746025318180 TABLET in 1 BOTTLE (53746-253-18) 180 tablet2009-12-160000-00-00NoNoCurrent
53746-253-605374602536060 TABLET in 1 BOTTLE (53746-253-60) 60 tablet2009-12-160000-00-00NoNoCurrent