Home NDC 0121-1025 Cimetidine Hydrochloride
Product NDC 0121-1025
11-digit product format 001211025
Labeler code 0121
Product ID 0121-1025_55abdac4-2b7c-4163-bf5f-d2e934108ba6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cimetidine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA074664
Marketing category ANDA
Marketing start 2025-01-09
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 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Cimetidine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIMETIDINE HYDROCHLORIDE 300 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WF10491673 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 212787 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-1025-08 Cimetidine Hydrochloride 237 mL in 1 BOTTLE SOLUTION 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1025 CIMETIDINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 5 Current NDC, 1 package rows 20250110_b8b50bd9-bc1b-4da5-96c5-8eb917c8937f.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 Sample Exclude flag Status 0121-1025-08 00121102508 237 mL in 1 BOTTLE (0121-1025-08) 237 ml 2025-01-09 No No Current