Home NDC 50383-051 Ranitidine
Product NDC 50383-051
11-digit product format 503830051
Labeler code 50383
Product ID 50383-051_4029ac91-63f2-4319-bd98-c80865fd4615
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form SOLUTION
Route ORAL
Labeler Hi-Tech Pharmacal Co., Inc.
Application ANDA091078
Marketing category ANDA
Marketing start 2011-03-22
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 No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091078-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22
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 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50383-051-04 2020-05-19 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-11 2020-05-19 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-12 2020-05-19 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-16 2020-05-19 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-04 2020-01-31 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-11 2020-01-31 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-12 2020-01-31 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-16 2020-01-31 C162847 48780-1 9d75b9d0-a22e-f424-e053-dadaa90a57ce RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP)
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 ALCOHOL INACTIVE INGREDIENT 3K9958V90M RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 SORBITOL INACTIVE INGREDIENT 506T60A25R RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R RANITIDINE SOLUTION [HI-TECH PHARMACAL CO., INC.] 7 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R RANITIDINE (RANITIDINE HYDROCHLORIDE) SOLUTION [PHYSICIANS TOTAL CARE, INC.] 3