Cimetidine

Product NDC: 0093-8192
11-digit product format: 000938192
Labeler code: 0093
Product ID: 0093-8192_e1f40596-aa5b-46a4-b2aa-add1150ac3a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cimetidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA074151
Marketing category: ANDA
Marketing start: 2003-11-24
Substance: CIMETIDINE
Active strength: 300 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: Cimetidine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIMETIDINE	300 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	80061L1WGD
Rxcui	197506, 197507, 197508

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f48ba86-02a3-4def-9efa-3a8140fd7adf	Product name	2	20250624
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-8192-01	Cimetidine	100 in 1 BOTTLE	TABLET, FILM COATED	100		11
0093-8192-05	Cimetidine	500 in 1 BOTTLE	TABLET, FILM COATED	500		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-8192-01	EA - Each	0093-8192	51ea6f86-289a-44f3-ae5f-b31afb2eceff	1	2012-07-24
0093-8192-05	EA - Each	0093-8192	84432a80-28f2-4883-97c3-1fa59c59bce0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CIMETIDINE	ACTIVE INGREDIENT	80061L1WGD	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CIMETIDINE	ACTIVE INGREDIENT	80061L1WGD	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POVIDONE K26/28	INACTIVE INGREDIENT	H7AGY1OJO8	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
CIMETIDINE	ACTIVE INGREDIENT	80061L1WGD	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
CIMETIDINE	ACTIVE INGREDIENT	80061L1WGD	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-8192	CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20230717_496e258d-a5fd-42da-9a86-73afc8be359b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80061L1WGD	CIMETIDINE	51481-61-9	CIMETIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197506	cimetidine 300 MG Oral Tablet	PSN	0ab5ea2b-bd2f-49ec-9e92-033bed998797	1008
197506	cimetidine 300 MG Oral Tablet	SCD	0ab5ea2b-bd2f-49ec-9e92-033bed998797	1008
197506	cimetidine 300 MG Oral Tablet	PSN	cf1626a1-ccf6-4759-b2ab-22c7f3873d84	24
197507	cimetidine 400 MG Oral Tablet	PSN	cf1626a1-ccf6-4759-b2ab-22c7f3873d84	24
197506	cimetidine 300 MG Oral Tablet	SCD	cf1626a1-ccf6-4759-b2ab-22c7f3873d84	24
197507	cimetidine 400 MG Oral Tablet	SCD	cf1626a1-ccf6-4759-b2ab-22c7f3873d84	24
197506	cimetidine 300 MG Oral Tablet	PSN	496e258d-a5fd-42da-9a86-73afc8be359b	11
197507	cimetidine 400 MG Oral Tablet	PSN	496e258d-a5fd-42da-9a86-73afc8be359b	11
197508	cimetidine 800 MG Oral Tablet	PSN	496e258d-a5fd-42da-9a86-73afc8be359b	11
197506	cimetidine 300 MG Oral Tablet	SCD	496e258d-a5fd-42da-9a86-73afc8be359b	11
197507	cimetidine 400 MG Oral Tablet	SCD	496e258d-a5fd-42da-9a86-73afc8be359b	11
197508	cimetidine 800 MG Oral Tablet	SCD	496e258d-a5fd-42da-9a86-73afc8be359b	11
197506	cimetidine 300 MG Oral Tablet	PSN	e35846d8-1647-46fa-b304-70f6fc7447e2	4
197506	cimetidine 300 MG Oral Tablet	SCD	e35846d8-1647-46fa-b304-70f6fc7447e2	4
197506	cimetidine 300 MG Oral Tablet	PSN	0fb333e0-5169-5f7a-e054-00144ff88e88	2
197507	cimetidine 400 MG Oral Tablet	PSN	0fb333e0-5169-5f7a-e054-00144ff88e88	2
197506	cimetidine 300 MG Oral Tablet	SCD	0fb333e0-5169-5f7a-e054-00144ff88e88	2
197507	cimetidine 400 MG Oral Tablet	SCD	0fb333e0-5169-5f7a-e054-00144ff88e88	2
197506	cimetidine 300 MG Oral Tablet	PSN	b235425c-1824-4e91-ac8d-5d6f745e3cdd	1
197506	cimetidine 300 MG Oral Tablet	SCD	b235425c-1824-4e91-ac8d-5d6f745e3cdd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-8192-01	00093819201	100 TABLET, FILM COATED in 1 BOTTLE (0093-8192-01)	2003-11-24	0000-00-00	No	No	Current
0093-8192-05	00093819205	500 TABLET, FILM COATED in 1 BOTTLE (0093-8192-05)	2004-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CIMETIDINE TABLETS USP 8192 8204 8305 Rx only	Bryant Ranch Prepack	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	1008
Cimetidine Tablets , USP Rx only	A-S Medication Solutions	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	24
Cimetidine Tablets , USP Rx only	Teva Pharmaceuticals USA, Inc.	2022-11-30	HUMAN PRESCRIPTION DRUG LABEL	11
CIMETIDINE TABLETS USP 8192 8204 8305 Rx only	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
CIMETIDINE TABLETS USP 8192 8204 8305 Rx only	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
CIMETIDINE TABLETS USP 8192 8204 8305 Rx only	Blenheim Pharmacal, Inc.	2015-03-02	HUMAN PRESCRIPTION DRUG LABEL	2

Cimetidine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#