Cimetidine

Product NDC
42291-217
11-digit product format
422910217
Labeler code
42291
Product ID
42291-217_9c5c5e16-f289-a7d7-e053-2995a90a7486
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA074151
Marketing category
ANDA
Marketing start
2016-01-12
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-217DDiscontinued by firm2026-08-17
excluded packagepackage42291-21742291-217-90DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-217-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-217-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-217-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-217-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-217-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-217-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-217-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-217-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-217-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-217-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-217-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-217-90557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074151-001CIMETIDINECIMETIDINE200MGTABLET / ORALAB1994-05-17
A074151-002CIMETIDINECIMETIDINE300MGTABLET / ORALAB1994-05-17
A074151-003CIMETIDINECIMETIDINE400MGTABLET / ORALAB1994-05-17

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-17caaa826d4ba7…
2026-08-18 06:07:402026-07A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-17caaa826d4ba7…
2026-08-18 06:07:402026-07A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074151-002CIMETIDINE300MGTABLET / ORALAB1994-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074151-003CIMETIDINE400MGTABLET / ORALAB1994-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074151-001CIMETIDINE200MGTABLET / ORALAB1994-05-171e350fbaab3a…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074151-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074151-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074151-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074151-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074151-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074151-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074151-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074151-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074151-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074151-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074151-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074151-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074151-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074151-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074151-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074151-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074151-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074151-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074151-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074151-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074151-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074151-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074151-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074151-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074151-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074151-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074151-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074151-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074151-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074151-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074151-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074151-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074151-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074151-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074151-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074151-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074151-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074151-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074151-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074151-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-217-90EA - Each42291-2179fdcfab9-4568-4b8f-8a42-f52879aeb8f212016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
CIMETIDINEACTIVE MOIETY80061L1WGDCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCIMETIDINE (CIMETIDINE) TABLET, FILM COATED [AVKARE, INC.]1

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CimetidineCIMETIDINEBryant Ranch Prepack0ab5ea2b-bd2f-49ec-9e92-033bed9987972026-03-09Adverse reactionsExact identifier
application applno (ANDA): 074151
application number: ANDA074151
CimetidineCIMETIDINEA-S Medication Solutionscf1626a1-ccf6-4759-b2ab-22c7f3873d842024-11-08Adverse reactionsExact identifier
application applno (ANDA): 074151
application number: ANDA074151
CimetidineCIMETIDINEProficient Rx LP5c2e1f52-4021-4f70-9b2b-63af170941872024-04-01Adverse reactionsExact identifier
application applno (ANDA): 074151
application number: ANDA074151
CimetidineCIMETIDINETeva Pharmaceuticals USA, Inc.496e258d-a5fd-42da-9a86-73afc8be359b2022-11-30Adverse reactionsExact identifier
application applno (ANDA): 074151
application number: ANDA074151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-217-904229102179090 TABLET, FILM COATED in 1 BOTTLE (42291-217-90) 2016-01-120000-00-00NoNoCurrent