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
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 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2011-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2011-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2011-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2011-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091078-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2011-03-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50383-051-04 2020-05-19 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-11 2020-05-19 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-12 2020-05-19 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-16 2020-05-19 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-04 2020-01-31 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-11 2020-01-31 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-12 2020-01-31 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 50383-051-16 2020-01-31 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