Chemet

Product NDC
55292-201
11-digit product format
552920201
Labeler code
55292
Product ID
55292-201_399a2f13-1fa5-5557-e063-6294a90a48a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
succimer
Dosage form
CAPSULE
Route
ORAL
Labeler
Recordati Rare Diseases, Inc.
Application
NDA019998
Marketing category
NDA
Marketing start
2013-08-21
Substance
SUCCIMER
Active strength
100 mg/1
Pharmacologic classes
Lead Chelating Activity [MoA], Lead Chelator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019998-002CHEMETSUCCIMER100MGCAPSULE / ORALRLD, RS1991-01-30

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019998-002CHEMET100MGCAPSULE / ORALRLD, RS1991-01-30cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Chemet
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCCIMER100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DX1U2629QEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198227Internal RxNorm lookup
207949Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62035612-9505-3a3f-1ac8-e2dbd711d24eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2f5edee6-054b-4e78-9516-4902240bd895Product name120221206
67641ec0-7553-6d3f-05ca-04c54d959119Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55292-201-11Chemet100 in 1 BOTTLECAPSULE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55292-201-11EA - Each55292-2017cda149d-bca1-4c4d-bb86-f88d3e3cf42912013-12-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55292-201CHEMET (SUCCIMER) CAPSULE [RECORDATI RARE DISEASES, INC.]9Current NDC, Legacy NDC, 1 package rows20240927_62035612-9505-3a3f-1ac8-e2dbd711d24e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemetSUCCIMERRecordati Rare Diseases, Inc.62035612-9505-3a3f-1ac8-e2dbd711d24e2025-07-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019998
application number: NDA019998
ndc (product): 55292-201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207949Chemet 100 MG Oral CapsulePSN62035612-9505-3a3f-1ac8-e2dbd711d24e10
198227succimer 100 MG Oral CapsulePSN62035612-9505-3a3f-1ac8-e2dbd711d24e10
207949succimer 100 MG Oral Capsule [Chemet]SBD62035612-9505-3a3f-1ac8-e2dbd711d24e10
198227succimer 100 MG Oral CapsuleSCD62035612-9505-3a3f-1ac8-e2dbd711d24e10
207949Chemet 100 MG Oral CapsuleSY62035612-9505-3a3f-1ac8-e2dbd711d24e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55292-201-1155292020111100 CAPSULE in 1 BOTTLE (55292-201-11) 100 capsule2013-08-210000-00-00NoNoCurrent