Ranitidine

Product NDC
50268-721
11-digit product format
502680721
Labeler code
50268
Product ID
50268-721_89175238-3add-22cd-e053-2a95a90ad3f0
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA210243
Marketing category
ANDA
Marketing start
2019-05-17
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50268-721DDiscontinued by firm2026-08-03
excluded packagepackage50268-72150268-721-15DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 10 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct50268-721IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50268-72150268-721-15IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct50268-721IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50268-72150268-721-15IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct50268-721IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50268-72150268-721-15IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct50268-721IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50268-72150268-721-15IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct50268-721IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50268-72150268-721-15IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-721-152024-12-10C16284748780-11030e365-3fd3-111a-e063-dadaa90a10e2Ranitidine Tablets, USP
50268-721-152024-01-30C16284748780-11030e365-3fd3-111a-e063-dadaa90a10e2Ranitidine Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-721-11EA - Each50268-72136748395-662d-4f77-a6aa-95b0f14c484712019-11-12
50268-721-15EA - Each50268-72167112ddb-387c-4427-9250-8235830882d012019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-721-155026807211550 BLISTER PACK in 1 BOX (50268-721-15) > 1 TABLET in 1 BLISTER PACK (50268-721-11) 50 blister pack2019-05-170000-00-00NoNoCurrent