TRIENTINE HYDROCHLORIDE

Product NDC
31722-683
11-digit product format
317220683
Labeler code
31722
Product ID
31722-683_e53ee9ec-7121-2b81-e053-2a95a90afe9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIENTINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216356
Marketing category
ANDA
Marketing start
2022-06-23
Substance
TRIENTINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Metal Chelating Activity [MoA], Metal 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
A216356-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2022-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216356-001AB

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
2026-08-01 22:54:322026-06A216356-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2022-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216356-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDECamber Pharmaceuticals, Inc.5240e3de-54b6-4f22-9142-776f0e9ea1d92022-08-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216356
application number: ANDA216356
ndc (product): 31722-683

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIENTINE HYDROCHLORIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HC3NX54582Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313472Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5240e3de-54b6-4f22-9142-776f0e9ea1d9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a68ac59a-f073-3e03-cd2c-70c7eb201ed2Product name820230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-683-01TRIENTINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001
31722-683-01TRIENTINE HYDROCHLORIDE1 in 1 CARTONCAPSULE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-683-01EA - Each31722-683f79a0711-9778-4cb4-9fbc-eedee10eb0f312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-683TRIENTINE HYDROCHLORIDE (TRIENTINE HYDROCHLORIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20220804_5240e3de-54b6-4f22-9142-776f0e9ea1d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313472trientine HCl 250 MG Oral CapsulePSN5240e3de-54b6-4f22-9142-776f0e9ea1d91
313472trientine hydrochloride 250 MG Oral CapsuleSCD5240e3de-54b6-4f22-9142-776f0e9ea1d91
313472trientine HCl 250 MG Oral CapsuleSY5240e3de-54b6-4f22-9142-776f0e9ea1d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-683-01317220683011 BOTTLE in 1 CARTON (31722-683-01) / 100 CAPSULE in 1 BOTTLE1 bottle2022-06-230000-00-00NoNoCurrent