Home NDC 63029-222 Tagamet
Product NDC 63029-222
11-digit product format 630290222
Labeler code 63029
Product ID 63029-222_e29142a4-59e0-4f6d-8a1f-3050b21491a2
Type HUMAN OTC DRUG
Nonproprietary name Cimetidine
Dosage form TABLET
Route ORAL
Labeler Medtech Products Inc.
Application NDA020238
Marketing category NDA
Marketing start 2012-06-01
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 1 .
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date N020238-001 TAGAMET HB CIMETIDINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 N020238-002 TAGAMET HB CIMETIDINE 200MG TABLET / ORAL RLD, RS 1996-08-21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 · 82 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 2026-02-19 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UTC 2026-02 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS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of this ZIP 2025-12 N020238-001 TAGAMET HB 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020238-002 TAGAMET HB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…2021-12-28 21:50 UTC 2021-12 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 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020238-002 TAGAMET HB 200MG TABLET / ORAL RLD, RS 1996-08-21 782e0a99824c…
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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63029-222 TAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.] 9 Current NDC, Legacy NDC, 20 package rows 20240621_e6401e0a-8612-42e8-bf89-2d67243f28dc.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 Marketing end Sample Exclude flag Status 63029-222-01 63029022201 1 BLISTER PACK in 1 BOX (63029-222-01) / 30 TABLET in 1 BLISTER PACK 1 blister pack 2012-06-01 0000-00-00 No No Current 63029-222-02 63029022202 1 BLISTER PACK in 1 BOX (63029-222-02) / 6 TABLET in 1 BLISTER PACK 1 blister pack 2012-06-01 0000-00-00 No No Current 63029-222-03 63029022203 1 BLISTER PACK in 1 BOX (63029-222-03) / 50 TABLET in 1 BLISTER PACK 1 blister pack 2012-06-01 0000-00-00 No No Current 63029-222-04 63029022204 4 BLISTER PACK in 1 BOX (63029-222-04) / 10 TABLET in 1 BLISTER PACK 4 blister pack 2019-06-01 0000-00-00 No No Current 63029-222-05 63029022205 4 BLISTER PACK in 1 BOX (63029-222-05) / 9 TABLET in 1 BLISTER PACK 4 blister pack 2019-06-01 0000-00-00 No No Current 63029-222-06 63029022206 7 BLISTER PACK in 1 BOX (63029-222-06) / 10 TABLET in 1 BLISTER PACK 7 blister pack 2012-06-01 0000-00-00 No No Current 63029-222-09 63029022209 1 BOTTLE in 1 CARTON (63029-222-09) / 90 TABLET in 1 BOTTLE 1 bottle 2012-06-01 0000-00-00 No No Current 63029-222-11 63029022211 1 BOTTLE in 1 CARTON (63029-222-11) / 100 TABLET in 1 BOTTLE 1 bottle 2012-06-01 0000-00-00 No No Current 63029-222-12 63029022212 2 BLISTER PACK in 1 BOX (63029-222-12) / 6 TABLET in 1 BLISTER PACK 2 blister pack 2012-06-01 0000-00-00 No No Current 63029-222-70 63029022270 1 BOTTLE in 1 CARTON (63029-222-70) / 70 TABLET in 1 BOTTLE 1 bottle 2012-06-01 0000-00-00 No No Current