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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	0093-8192		UNFINISHED	Active or certified unfinished drug listing		2026-08-17
unfinished package	package	0093-8192	0093-8192-99	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0093-8192-99	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0093-8192-99	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0093-8192-99	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0093-8192-99	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0093-8192-99	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0093-8192-99	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0093-8192-99	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0093-8192-99	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0093-8192-99	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0093-8192-99	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0093-8192-99	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0093-8192-99	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0093-8192-99	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0093-8192-99	`50b4072663b7…`	`eae3003ed65e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074151-001	CIMETIDINE	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17
A074151-002	CIMETIDINE	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17
A074151-003	CIMETIDINE	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074151-001	AB
A074151-002	AB
A074151-003	AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074151-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074151-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074151-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074151-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-001	AB	1	`1e350fbaab3a…`

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 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197506	Internal RxNorm lookup
197507	Internal RxNorm lookup
197508	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
496e258d-a5fd-42da-9a86-73afc8be359b	Available on FDA.report

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 [CARILION MATERIALS MANAGEMENT]	2
CIMETIDINE	ACTIVE INGREDIENT	80061L1WGD	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	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 [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	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 [BLENHEIM PHARMACAL, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	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 [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	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
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	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 [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	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
CIMETIDINE	ACTIVE INGREDIENT	80061L1WGD	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
CIMETIDINE	ACTIVE MOIETY	80061L1WGD	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]	1

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

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cimetidine	CIMETIDINE	Bryant Ranch Prepack	0ab5ea2b-bd2f-49ec-9e92-033bed998797	2026-03-09	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151
Cimetidine	CIMETIDINE	A-S Medication Solutions	cf1626a1-ccf6-4759-b2ab-22c7f3873d84	2024-11-08	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151
Cimetidine	CIMETIDINE	Proficient Rx LP	5c2e1f52-4021-4f70-9b2b-63af17094187	2024-04-01	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151
Cimetidine	CIMETIDINE	Teva Pharmaceuticals USA, Inc.	496e258d-a5fd-42da-9a86-73afc8be359b	2022-11-30	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151 ndc (product): 0093-8192

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
0093-8192-99	00093819299	39063 TABLET, FILM COATED in 1 PAIL (0093-8192-99)	30-MAR-23				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 Rx only	AvKARE, Inc.	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
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