Tagamet

Manufacturer: Medtech Products Inc.
Effective date: 2024-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:13:55

Label at a glance#

ProductTagamet

Active ingredientCIMETIDINE

Label structure12 sections

Indications and uses

relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Dosage and administration

adults and children 12 years and over: ▪ to relieve symptoms, swallow 1 tablet with a glass of water ▪ to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn ▪ do not take more than 2 tablets in 24 hours children under 12 years: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-482-4394

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cimetidine 200mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to cimetidine or other acid reducers.

Do not use

OTC - DO NOT USE SECTION

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
kidney disease
liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking a prescription drug.

Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you need to take this product for more than 14 days
stomach pain continues
your heartburn continues or worsens

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over:
▪ to relieve symptoms, swallow 1 tablet with a glass of water
▪ to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn
▪ do not take more than 2 tablets in 24 hours
children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

store at 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-482-4394 weekdays

tagamet.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer
70 tablets (70 doses)

PRINCIPAL DISPLAY PANEL Tagamet® HB 200 Cimetidine Tablets 200 mg Acid Reducer 70 tablets (70 doses)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer

30 tablets (30 doses)

PRINCIPAL DISPLAY PANEL Tagamet® HB 200 Cimetidine Tablets 200 mg Acid Reducer 30 tablets (30 doses)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tagamet ® HB 200
Cimetidine Tablets 200 mg
Acid Reducer

6 tablets (6 doses)

Tagamet ® HB 200 Cimetidine Tablets 200 mg Acid Reducer 6 tablets (6 doses)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197505	cimetidine 200 MG Oral Tablet	PSN	9
104062	Tagamet HB 200 MG Oral Tablet	PSN	9
104062	cimetidine 200 MG Oral Tablet [Tagamet]	SBD	9
197505	cimetidine 200 MG Oral Tablet	SCD	9
104062	Tagamet 200 MG Oral Tablet	SY	9
104062	Tagamet HB 200 MG Oral Tablet	SY	9

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CIMETIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f48ba86-02a3-4def-9efa-3a8140fd7adf	Product name	2	20250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63029-222-01	Tagamet	30 in 1 BLISTER PACK	TABLET	30	9
63029-222-01	Tagamet	1 in 1 BOX	TABLET	1	9
63029-222-02	Tagamet	6 in 1 BLISTER PACK	TABLET	6	9
63029-222-02	Tagamet	1 in 1 BOX	TABLET	1	9
63029-222-03	Tagamet	50 in 1 BLISTER PACK	TABLET	50	9
63029-222-03	Tagamet	1 in 1 BOX	TABLET	1	9
63029-222-04	Tagamet	4 in 1 BOX	TABLET	4	9
63029-222-04	Tagamet	10 in 1 BLISTER PACK	TABLET	10	9
63029-222-05	Tagamet	4 in 1 BOX	TABLET	4	9
63029-222-05	Tagamet	9 in 1 BLISTER PACK	TABLET	9	9
63029-222-06	Tagamet	7 in 1 BOX	TABLET	7	9
63029-222-06	Tagamet	10 in 1 BLISTER PACK	TABLET	10	9
63029-222-09	Tagamet	90 in 1 BOTTLE	TABLET	90	9
63029-222-09	Tagamet	1 in 1 CARTON	TABLET	1	9
63029-222-11	Tagamet	1 in 1 CARTON	TABLET	1	9
63029-222-11	Tagamet	100 in 1 BOTTLE	TABLET	100	9
63029-222-12	Tagamet	6 in 1 BLISTER PACK	TABLET	6	9
63029-222-12	Tagamet	2 in 1 BOX	TABLET	2	9
63029-222-70	Tagamet	1 in 1 CARTON	TABLET	1	9
63029-222-70	Tagamet	70 in 1 BOTTLE	TABLET	70	9
63029-223-30	Tagamet	10 in 1 BLISTER PACK	TABLET	10	9
63029-223-30	Tagamet	3 in 1 BOX	TABLET	3	9

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
63029-223	TAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]	9	Current NDC, 2 package rows	20240621_e6401e0a-8612-42e8-bf89-2d67243f28dc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63029-222-01	EA - Each	63029-222	018efaa5-5ae1-4f22-8d25-4f421612d223	1	2022-06-06
63029-222-02	EA - Each	63029-222	df825d83-df13-4c32-9244-6540af20c15b	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CIMETIDINE	ACTIVE INGREDIENT	80061L1WGD	3
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	3
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Tagamet
Cimetidine
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
MICROCRYSTALLINE CELLULOSE
FD&C BLUE NO. 1 ALUMINUM LAKE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63029-222	63029-222-02, 63029-222-01, 63029-222-03, 63029-222-04, 63029-222-05, 63029-222-70, 63029-222-06, 63029-222-09, 63029-222-11, 63029-222-12
63029-223	63029-223-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CIMETIDINE	80061L1WGD	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
CIMETIDINE	80061L1WGD	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 104 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`84e616aacf4f…`
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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tagamet	CIMETIDINE	Medtech Products Inc.	e6401e0a-8612-42e8-bf89-2d67243f28dc	2024-06-10	Warnings	Exact identifier ndc (package): 63029-222-11 ndc (package): 63029-222-02 ndc (package): 63029-222-70 ndc (package): 63029-223-30 ndc (package): 63029-222-04 ndc (package): 63029-222-09 ndc (package): 63029-222-12 ndc (package): 63029-222-01 ndc (package): 63029-222-03 ndc (package): 63029-222-06 ndc (package): 63029-222-05 ndc (product): 63029-223 ndc (product): 63029-222 ndc11 (package): 63029022202 ndc11 (package): 63029022204 ndc11 (package): 63029022212 ndc11 (package): 63029022211 ndc11 (package): 63029022206 ndc11 (package): 63029022270 ndc11 (package): 63029022209 ndc11 (package): 63029022205 ndc11 (package): 63029022330 ndc11 (package): 63029022201 ndc11 (package): 63029022203 spl id: e29142a4-59e0-4f6d-8a1f-3050b21491a2 spl set id: e6401e0a-8612-42e8-bf89-2d67243f28dc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.