FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
24658-341
11-digit product format
246580341
Labeler code
24658
Product ID
24658-341_7ef51c90-f18d-219c-e053-2991aa0a7440
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application
ANDA075401
Marketing category
ANDA
Marketing start
2003-04-10
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24658-341DDiscontinued by firm2026-07-31
excluded packagepackage24658-34124658-341-30DDiscontinued by firm2026-07-31
excluded packagepackage24658-34124658-341-90DDiscontinued by firm2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075401-001TAZTIA XTDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-002TAZTIA XTDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-003TAZTIA XTDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-004TAZTIA XTDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-005TAZTIA XTDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10

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 22:54:322026-06A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24658-341-302025-01-28C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)
24658-341-902025-01-28C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)
24658-341-302020-09-27C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)
24658-341-902020-09-27C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)
24658-341-302020-09-25C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)
24658-341-902020-09-25C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)
24658-341-302020-07-22C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)
24658-341-902020-07-22C16284748780-1ab0e2407-2a70-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules USP (Once-A-Day Dosage)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-341-30EA - Each24658-3416f40c310-1486-4a70-8bac-143b5629c24212017-08-11
24658-341-90EA - Each24658-34165507a92-7e79-438d-93d6-c932919976c812017-08-11