Chlorpheniramine Maleate

Product NDC
37205-117
11-digit product format
372050117
Labeler code
37205
Product ID
37205-117_f2f01039-1739-493f-8b6f-3c0e68c6bda3
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health, Inc.
Application
ANDA040829
Marketing category
ANDA
Marketing start
2010-12-20
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE
Active strength
12 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct37205-117DDiscontinued by firm2026-08-17
excluded packagepackage37205-11737205-117-62DDiscontinued 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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37205-117-62DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-117-62DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-117-62IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-117-62IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-117-62IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-117-62IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-117-62IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-117-62IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-117-62IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-117-62IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-117-62IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-117-62IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage37205-117-62IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage37205-117-62IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage37205-117-62IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage37205-117-62IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage37205-117-62IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage37205-117-62IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage37205-117-62IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage37205-117-62IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage37205-117-62IInactivated by FDA9bebd1f3094a…5416666fcb17…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040829-001CHLORPHENIRAMINE MALEATECHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-117-622025-04-04C16284748780-19d75b9d0-0397-f424-e053-dadaa90a57ceUnknown Title
37205-117-622020-01-31C16284748780-19d75b9d0-0397-f424-e053-dadaa90a57ceUnknown Title

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-117-62EA - Each37205-117c2c57ce1-8d4d-4f27-b2d1-66e835efdd8d12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH, 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorphen-12CHLORPHENIRAMINE MALEATEKVK-Tech, Inc.84409269-fe9b-469e-9a66-27b1475231a32018-12-19WarningsExact identifier
application applno (ANDA): 040829
application number: ANDA040829
Allergy ReliefCHLORPHENIRAMINE MALEATECVS Pharmacy626aa162-f5e3-45c0-b5ac-d70bff255aed2017-01-19WarningsExact identifier
application applno (ANDA): 040829
application number: ANDA040829