Home NDC 50383-050-08 Cimetidine Hydrochloride Oral Solution
Product NDC 50383-050
Requested package NDC 50383-050-08
11-digit product format 503830050
Labeler code 50383
Product ID 50383-050_283fc6ae-681a-419b-b155-dab73acf4403
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cimetidine Hydrochloride Oral Solution
Dosage form SOLUTION
Route ORAL
Labeler Akorn Operating Company LLC
Application ANDA074664
Marketing category ANDA
Marketing start 1997-10-28
Marketing end 0000-00-00
Substance CIMETIDINE HYDROCHLORIDE
Active strength 300 mg/5mL
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A074664-001 CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074664-001 AA
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 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL RS 1997-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL RS 1997-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50383-050-08 Cimetidine Hydrochloride Oral Solution 237 mL in 1 BOTTLE SOLUTION 237 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIMETIDINE HYDROCHLORIDE ACTIVE INGREDIENT WF10491673 CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 CIMETIDINE ACTIVE MOIETY 80061L1WGD CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 ORANGE INACTIVE INGREDIENT 5EVU04N5QU CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 SODIUM PHOSPHATE, DIBASIC ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-050 CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [AKORN OPERATING COMPANY LLC] 4 Legacy NDC, 1 package rows 20221018_f2ec923a-2b88-43c0-ac2a-7ae20c053039.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 50383-050-08 50383005008 237 mL in 1 BOTTLE (50383-050-08) 237 ml 1997-10-28 0000-00-00 No No Current