Ranitidine

Product NDC
27241-110
11-digit product format
272410110
Labeler code
27241
Product ID
27241-110_d7fd99da-f17a-4124-9014-70bbe43d78f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA209859
Marketing category
ANDA
Marketing start
2018-09-27
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 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 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
A209859-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27
A209859-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27

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 06:07:402026-07A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27caaa826d4ba7…
2026-08-18 06:07:402026-07A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-09-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-09-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209859-001RANITIDINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2018-09-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209859-002RANITIDINE HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2018-09-27bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209859-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209859-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A209859-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A209859-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209859-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209859-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209859-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209859-002AB1ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE HYDROCHLORIDE300 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
198190Internal RxNorm lookup
198192Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb67e8c7-b817-4253-a1a1-5ecdcee694cfAvailable 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
27241-110-03Ranitidine30 in 1 BOTTLECAPSULE304
27241-110-10Ranitidine100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-110-03EA - Each27241-1107e28ffc9-a2a9-41a2-8c92-15f6ed98b8cb12018-12-13
27241-110-10EA - Each27241-1103097197a-df20-486d-a3c4-1e4332f26f6c12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-110RANITIDINE CAPSULE [AJANTA PHARMA USA INC.]4Current NDC, Legacy NDC, 2 package rows20211124_fb67e8c7-b817-4253-a1a1-5ecdcee694cf.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
RanitidineRANITIDINEAjanta Pharma USA Inc.fb67e8c7-b817-4253-a1a1-5ecdcee694cf2021-11-24Adverse reactionsExact identifier
application applno (ANDA): 209859
application number: ANDA209859
ndc (product): 27241-110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198190ranitidine 150 MG Oral CapsuleSCDfb67e8c7-b817-4253-a1a1-5ecdcee694cf4
198192ranitidine 300 MG Oral CapsuleSCDfb67e8c7-b817-4253-a1a1-5ecdcee694cf4
198190ranitidine 150 MG (ranitidine HCl 168 MG) Oral CapsuleSYfb67e8c7-b817-4253-a1a1-5ecdcee694cf4
198192ranitidine 300 MG (ranitidine HCl 336 MG) Oral CapsuleSYfb67e8c7-b817-4253-a1a1-5ecdcee694cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-110-032724101100330 CAPSULE in 1 BOTTLE (27241-110-03) 30 capsule2018-09-270000-00-00NoNoCurrent
27241-110-1027241011010100 CAPSULE in 1 BOTTLE (27241-110-10) 100 capsule2018-09-270000-00-00NoNoCurrent