FDA.reportPublic FDA data

Ranitidine 150

Product NDC
69168-397
11-digit product format
691680397
Labeler code
69168
Product ID
69168-397_269ed013-0691-4a9c-944b-5702f022eee1
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine HCl Tablets 150mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Allegiant Health
Application
ANDA210243
Marketing category
ANDA
Marketing start
2018-10-01
Marketing end
2021-04-30
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69168-397DDiscontinued by firm2026-08-03
excluded packagepackage69168-39769168-397-03DDiscontinued by firm2026-08-03
excluded packagepackage69168-39769168-397-29DDiscontinued by firm2026-08-03
excluded packagepackage69168-39769168-397-93DDiscontinued by firm2026-08-03

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20a50c72e98297…
2026-08-01 22:54:322026-06A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20a50c72e98297…

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-397-0369168039703250 TABLET, COATED in 1 BOTTLE (69168-397-03) 2018-10-012021-04-30NoNoCurrent
69168-397-29691680397291 BLISTER PACK in 1 CARTON (69168-397-29) > 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2018-10-012021-04-30NoNoCurrent
69168-397-93691680397932 BLISTER PACK in 1 CARTON (69168-397-93) > 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-10-012021-04-30NoNoCurrent