Home NDC 62207-774-58 Ranitidine
Product NDC 62207-774
Requested package NDC 62207-774-58
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210243-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2018-08-20 A210243-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2018-08-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A210243-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2018-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 A210243-002 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2018-08-20 a50c72e98297…
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.
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 Ingredient Strength RANITIDINE HYDROCHLORIDE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BK76465IHM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198191 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-774 RANITIDINE COOL MINT (RANITIDINE) TABLET RANITIDINE TABLET [GRANULES INDIA LTD] 10 Current NDC, Legacy NDC, 8 package rows 20241109_aab81d9f-397d-49fb-8083-77a1872cc71f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62207-774-58 62207077458 2 BLISTER PACK in 1 CARTON (62207-774-58) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2019-06-26 0000-00-00 No No Current