Ranitidine

Product NDC
62207-774
Requested package NDC
62207-774-47
11-digit product format
622070774
Labeler code
62207
Product ID
62207-774_44f2b222-ae43-eef4-e063-6394a90ab2b6
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA210243
Marketing category
ANDA
Marketing start
2019-06-26
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210243-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20
A210243-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RanitidineRANITIDINEGranules India Ltdaab81d9f-397d-49fb-8083-77a1872cc71f2025-12-02WarningsExact identifier
application applno (ANDA): 210243
application number: ANDA210243
ndc (package): 62207-774-47
ndc (product): 62207-774
ndc11 (package): 62207077447

Additional Listing Data#

Finished product
Yes
Brand name base
Ranitidine
Brand name suffix
cool mint
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aab81d9f-397d-49fb-8083-77a1872cc71fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-774-36Ranitidinecool mint5 in 1 CARTONTABLET511
62207-774-36Ranitidinecool mint10000 in 1 BAGTABLET1000011
62207-774-41Ranitidinecool mint1 in 1 CARTONTABLET111
62207-774-41Ranitidinecool mint24 in 1 BOTTLETABLET2411
62207-774-47Ranitidinecool mint1 in 1 CARTONTABLET111
62207-774-47Ranitidinecool mint500 in 1 BOTTLETABLET50011
62207-774-58Ranitidinecool mint10 in 1 BLISTER PACKTABLET1011
62207-774-58Ranitidinecool mint2 in 1 CARTONTABLET211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-774RANITIDINE COOL MINT (RANITIDINE) TABLET RANITIDINE TABLET [GRANULES INDIA LTD]10Current NDC, Legacy NDC, 8 package rows20241109_aab81d9f-397d-49fb-8083-77a1872cc71f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNaab81d9f-397d-49fb-8083-77a1872cc71f11
198191ranitidine 150 MG Oral TabletSCDaab81d9f-397d-49fb-8083-77a1872cc71f11
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYaab81d9f-397d-49fb-8083-77a1872cc71f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-774-47622070774471 BOTTLE in 1 CARTON (62207-774-47) / 500 TABLET in 1 BOTTLE1 bottle2019-06-260000-00-00NoNoCurrent