Cimetidine

Product NDC
50090-0499
11-digit product format
500900499
Labeler code
50090
Product ID
50090-0499_07557101-bc45-4c56-b622-be43d8156aa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074151
Marketing category
ANDA
Marketing start
2003-11-24
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0499DDiscontinued by firm2026-08-17
excluded packagepackage50090-049950090-0499-0DDiscontinued by firm2026-08-17
excluded packagepackage50090-049950090-0499-2DDiscontinued 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 · 36 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 packagepackage50090-0499-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0499-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0499-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0499-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0499-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0499-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0499-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0499-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0499-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0499-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0499-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0499-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0499-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0499-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0499-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0499-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0499-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0499-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0499-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0499-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0499-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0499-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0499-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0499-0557ba5c1ecfa…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 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
50090-0499-0Cimetidine30 in 1 BOTTLETABLET, FILM COATED3024
50090-0499-2Cimetidine21 in 1 BOTTLETABLET, FILM COATED2124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0499CIMETIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]24Legacy NDC, 2 package rows20241109_cf1626a1-ccf6-4759-b2ab-22c7f3873d84.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
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
ndc (product): 50090-0499
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197506cimetidine 300 MG Oral TabletPSNcf1626a1-ccf6-4759-b2ab-22c7f3873d8424
197507cimetidine 400 MG Oral TabletPSNcf1626a1-ccf6-4759-b2ab-22c7f3873d8424
197506cimetidine 300 MG Oral TabletSCDcf1626a1-ccf6-4759-b2ab-22c7f3873d8424
197507cimetidine 400 MG Oral TabletSCDcf1626a1-ccf6-4759-b2ab-22c7f3873d8424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0499-05009004990030 TABLET, FILM COATED in 1 BOTTLE (50090-0499-0) 2014-11-280000-00-00NoNoCurrent
50090-0499-25009004990221 in 1 BOTTLEHistorical