Ranitidine

Product NDC
17856-0664
11-digit product format
178560664
Labeler code
17856
Product ID
17856-0664_9d0f743b-84a7-4258-93d6-4ab6b573e400
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA078312
Marketing category
ANDA
Marketing start
2010-03-12
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
15 mg/mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0664IInactivated by FDA2026-08-17
excluded packagepackage17856-066417856-0664-2IInactivated by FDA2026-08-17
excluded packagepackage17856-066417856-0664-4IInactivated by FDA2026-08-17

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 2 · 66 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 packagepackage17856-0664-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0664-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0664-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0664-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0664-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0664-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0664-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0664-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0664-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0664-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0664-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0664-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0664-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0664-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0664-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0664-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0664-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0664-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0664-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0664-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0664-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0664-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0664-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0664-4557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0664-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0664-48af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0664-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0664-4834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0664-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0664-41332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0664-2fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0664-4fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0664-286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0664-486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0664-2bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0664-4bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17856-0664-28dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17856-0664-48dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-0664-2e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-0664-4e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078312-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAA2008-09-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAA2008-09-023f01610625f2…
2019-09-15 20:21 UTC2019-09A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAA2008-09-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAA2008-09-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078312-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2008-09-02e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078312-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A078312-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A078312-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078312-001AA1ea99ee380514…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0664-2Ranitidine10 mL in 1 CUPSOLUTION102
17856-0664-4Ranitidine1 mL in 1 SYRINGESOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0664-4ML - Milliliter17856-0664c6ff3b6d-2ae8-4c19-b8dd-83a1357f9b6512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SORBITOLINACTIVE INGREDIENT506T60A25RRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RRANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0664RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 2 package rows20140515_804ba82f-aaf6-46ec-8765-341c5ee2942a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705610ranitidine 15 MG/ML Oral SolutionSCD804ba82f-aaf6-46ec-8765-341c5ee2942a2
705610ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral SolutionSY804ba82f-aaf6-46ec-8765-341c5ee2942a2
705610ranitidine 75 MG per 5 ML SyrupSY804ba82f-aaf6-46ec-8765-341c5ee2942a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0664-21785606640210 mL in 1 CUP10 mlHistorical
17856-0664-4178560664041 mL in 1 SYRINGE1 mlHistorical