FDA.reportPublic FDA data

HEMICLOR

Product NDC
50742-285
11-digit product format
507420285
Labeler code
50742
Product ID
50742-285_2757ac31-07b3-4df2-80cc-f9918606c08a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
NDA218647
Marketing category
NDA
Marketing start
2025-03-17
Substance
CHLORTHALIDONE
Active strength
12.5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [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
N218647-001HEMICLORCHLORTHALIDONE12.5MGTABLET / ORALRLD, RS2025-03-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218647-001126675542045-09-04Drug product2026-07-02

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218647-001HEMICLOR12.5MGTABLET / ORALRLD, RS2025-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218647-001HEMICLOR12.5MGTABLET / ORALRLD, RS2025-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N218647-001HEMICLOR12.5MGTABLET / ORALRLD, RS2025-03-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218647-001HEMICLOR12.5MGTABLET / ORALRLD, RS2025-03-17a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218647-001126675542045-09-04Drug product2026-07-02a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORTHALIDONE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q0MQD1073QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
428539Internal RxNorm lookup
2709679Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f0f3ee0-f5a6-4bda-8160-a77744e9fa46Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83fe98fe-2a14-448c-9029-41f7600d1b0aProduct name120260105
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
8525e779-537f-e5cc-2515-089ecce5f50fProduct name920221128
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
3f5e2da3-8b99-f714-3261-2c998ee07b05Product name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-285-30HEMICLOR30 in 1 BOTTLETABLET301
50742-285-90HEMICLOR90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-285-30EA - Each50742-285dcca1d9c-a178-4f6f-9289-5acf1949dc9a12025-05-14
50742-285-90EA - Each50742-2855eeea435-c144-4893-9803-efe2bfff6e0d12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-285HEMICLOR (CHLORTHALIDONE) TABLET [INGENUS PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250402_3f0f3ee0-f5a6-4bda-8160-a77744e9fa46.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
HEMICLORCHLORTHALIDONEIngenus Pharmaceuticals, LLC3f0f3ee0-f5a6-4bda-8160-a77744e9fa462025-03-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 218647
application number: NDA218647
ndc (product): 50742-285

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
428539chlorthalidone 12.5 MG Oral TabletPSN3f0f3ee0-f5a6-4bda-8160-a77744e9fa461
2709679Hemiclor 12.5 MG Oral TabletPSN3f0f3ee0-f5a6-4bda-8160-a77744e9fa461
2709679chlorthalidone 12.5 MG Oral Tablet [Hemiclor]SBD3f0f3ee0-f5a6-4bda-8160-a77744e9fa461
428539chlorthalidone 12.5 MG Oral TabletSCD3f0f3ee0-f5a6-4bda-8160-a77744e9fa461
2709679Hemiclor 12.5 MG Oral TabletSY3f0f3ee0-f5a6-4bda-8160-a77744e9fa461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-285-305074202853030 TABLET in 1 BOTTLE (50742-285-30) 30 tablet2025-03-17NoNoCurrent
50742-285-905074202859090 TABLET in 1 BOTTLE (50742-285-90) 90 tablet2025-03-17NoNoCurrent