FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Tagamet
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui104062, 197505

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-222-01Tagamet30 in 1 BLISTER PACKTABLET309
63029-222-01Tagamet1 in 1 BOXTABLET19
63029-222-02Tagamet6 in 1 BLISTER PACKTABLET69
63029-222-02Tagamet1 in 1 BOXTABLET19
63029-222-03Tagamet50 in 1 BLISTER PACKTABLET509
63029-222-03Tagamet1 in 1 BOXTABLET19
63029-222-04Tagamet4 in 1 BOXTABLET49
63029-222-04Tagamet10 in 1 BLISTER PACKTABLET109
63029-222-05Tagamet4 in 1 BOXTABLET49
63029-222-05Tagamet9 in 1 BLISTER PACKTABLET99
63029-222-06Tagamet7 in 1 BOXTABLET79
63029-222-06Tagamet10 in 1 BLISTER PACKTABLET109
63029-222-09Tagamet90 in 1 BOTTLETABLET909
63029-222-09Tagamet1 in 1 CARTONTABLET19
63029-222-11Tagamet1 in 1 CARTONTABLET19
63029-222-11Tagamet100 in 1 BOTTLETABLET1009
63029-222-12Tagamet6 in 1 BLISTER PACKTABLET69
63029-222-12Tagamet2 in 1 BOXTABLET29
63029-222-70Tagamet1 in 1 CARTONTABLET19
63029-222-70Tagamet70 in 1 BOTTLETABLET709

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-222-01EA - Each63029-222018efaa5-5ae1-4f22-8d25-4f421612d22312022-06-06
63029-222-02EA - Each63029-222df825d83-df13-4c32-9244-6540af20c15b12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
CIMETIDINEACTIVE MOIETY80061L1WGDTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-222TAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]9Current NDC, Legacy NDC, 20 package rows20240621_e6401e0a-8612-42e8-bf89-2d67243f28dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSNe6401e0a-8612-42e8-bf89-2d67243f28dc9
104062Tagamet HB 200 MG Oral TabletPSNe6401e0a-8612-42e8-bf89-2d67243f28dc9
104062cimetidine 200 MG Oral Tablet [Tagamet]SBDe6401e0a-8612-42e8-bf89-2d67243f28dc9
197505cimetidine 200 MG Oral TabletSCDe6401e0a-8612-42e8-bf89-2d67243f28dc9
104062Tagamet 200 MG Oral TabletSYe6401e0a-8612-42e8-bf89-2d67243f28dc9
104062Tagamet HB 200 MG Oral TabletSYe6401e0a-8612-42e8-bf89-2d67243f28dc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-222-01630290222011 BLISTER PACK in 1 BOX (63029-222-01) / 30 TABLET in 1 BLISTER PACK1 blister pack2012-06-010000-00-00NoNoCurrent
63029-222-02630290222021 BLISTER PACK in 1 BOX (63029-222-02) / 6 TABLET in 1 BLISTER PACK1 blister pack2012-06-010000-00-00NoNoCurrent
63029-222-03630290222031 BLISTER PACK in 1 BOX (63029-222-03) / 50 TABLET in 1 BLISTER PACK1 blister pack2012-06-010000-00-00NoNoCurrent
63029-222-04630290222044 BLISTER PACK in 1 BOX (63029-222-04) / 10 TABLET in 1 BLISTER PACK4 blister pack2019-06-010000-00-00NoNoCurrent
63029-222-05630290222054 BLISTER PACK in 1 BOX (63029-222-05) / 9 TABLET in 1 BLISTER PACK4 blister pack2019-06-010000-00-00NoNoCurrent
63029-222-06630290222067 BLISTER PACK in 1 BOX (63029-222-06) / 10 TABLET in 1 BLISTER PACK7 blister pack2012-06-010000-00-00NoNoCurrent
63029-222-09630290222091 BOTTLE in 1 CARTON (63029-222-09) / 90 TABLET in 1 BOTTLE1 bottle2012-06-010000-00-00NoNoCurrent
63029-222-11630290222111 BOTTLE in 1 CARTON (63029-222-11) / 100 TABLET in 1 BOTTLE1 bottle2012-06-010000-00-00NoNoCurrent
63029-222-12630290222122 BLISTER PACK in 1 BOX (63029-222-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2012-06-010000-00-00NoNoCurrent
63029-222-70630290222701 BOTTLE in 1 CARTON (63029-222-70) / 70 TABLET in 1 BOTTLE1 bottle2012-06-010000-00-00NoNoCurrent