Home NDC 55289-581 Cimetidine
Product NDC 55289-581
11-digit product format 552890581
Labeler code 55289
Product ID 55289-581_419aec97-c220-0c91-e063-6294a90a67b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cimetidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA074246
Marketing category ANDA
Marketing start 1994-05-17
Substance CIMETIDINE
Active strength 400 mg/1
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 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074246-001 CIMETIDINE CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 A074246-002 CIMETIDINE CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 A074246-003 CIMETIDINE CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 A074246-004 CIMETIDINE CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 168 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 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cimetidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIMETIDINE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80061L1WGD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197507 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 55289-581-10 Cimetidine 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 13 55289-581-20 Cimetidine 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 13 55289-581-30 Cimetidine 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 13 55289-581-60 Cimetidine 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 13 55289-581-90 Cimetidine 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIMETIDINE ACTIVE INGREDIENT 80061L1WGD CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CIMETIDINE ACTIVE MOIETY 80061L1WGD CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 VANILLIN INACTIVE INGREDIENT CHI530446X CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-581 CIMETIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 Current NDC, Legacy NDC, 5 package rows 20241012_28fd7158-a617-436a-8f5c-71ffbaafe527.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-581-10 55289058110 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-10) 2015-11-02 0000-00-00 No No Current 55289-581-20 55289058120 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-20) 2015-11-02 0000-00-00 No No Current 55289-581-30 55289058130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30) 2015-11-02 0000-00-00 No No Current 55289-581-60 55289058160 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-60) 2015-11-02 0000-00-00 No No Current 55289-581-90 55289058190 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-90) 2015-11-02 0000-00-00 No No Current