Home NDC 65162-664 Ranitidine
Product NDC 65162-664
11-digit product format 651620664
Labeler code 65162
Product ID 65162-664_022a0dc5-868f-4c73-a9f9-a6cd4c7c5331
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA078312
Marketing category ANDA
Marketing start 2010-03-12
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 2023-12-31
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65162-664-90 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65162-664-90 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 65162-664-90 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 65162-664-90 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65162-664-90 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078312-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02
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 · 42 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 2026-08-18 06:07:40 2026-07 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2008-09-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2008-09-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2008-09-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA 2008-09-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078312-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2008-09-02 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-664 RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS LLC] 10 Legacy NDC 20241031_8f0bb213-6342-4fea-a080-24def590d1ba.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 65162-664-90 65162066490 473 mL in 1 BOTTLE (65162-664-90) 473 ml 2010-03-12 0000-00-00 No No Current