Home NDC 52183-223 TAGAMET
Product NDC 52183-223
11-digit product format 521830223
Labeler code 52183
Product ID 52183-223_e042ef55-48d2-43c6-91d1-55becd1f9f7c
Type HUMAN OTC DRUG
Nonproprietary name cimetidine
Dosage form TABLET
Route ORAL
Labeler Prestige Brands Holdings, Inc.
Application NDA020238
Marketing category NDA
Marketing start 2023-02-01
Substance CIMETIDINE
Active strength 200 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020238-001 TAGAMET HB CIMETIDINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 N020238-002 TAGAMET HB CIMETIDINE 200MG TABLET / ORAL RLD, RS 1996-08-21
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 3 · 84 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 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020238-001 TAGAMET HB 100MG TABLET / ORAL RLD 1995-06-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020238-001 TAGAMET HB 100MG TABLET / ORAL RLD 1995-06-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1995-06-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base TAGAMET
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIMETIDINE 200 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 104062 Internal RxNorm lookup 197505 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 52183-223-30 TAGAMET 10 in 1 BLISTER PACK TABLET 10 1 52183-223-30 TAGAMET 3 in 1 BOX TABLET 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52183-223 TAGAMET (CIMETIDINE) TABLET [PRESTIGE BRANDS HOLDINGS, INC.] 1 Current NDC, 2 package rows 20230201_c8ba8815-9d99-439f-b397-3869f729d9f4.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 · 2 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 52183-223-30 52183022330 3 BLISTER PACK in 1 BOX (52183-223-30) / 10 TABLET in 1 BLISTER PACK 3 blister pack 2023-02-01 No No Current