FDA.reportPublic FDA data

Cartia

Product NDC
50090-3051
Requested package NDC
50090-3051-1
11-digit product format
500903051
Labeler code
50090
Product ID
50090-3051_72ab8df9-1dc1-4677-8437-29f2448f8b8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074752
Marketing category
ANDA
Marketing start
1998-07-09
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-305150090-3051-1DDiscontinued 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074752-001CARTIA XTDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09
A074752-002CARTIA XTDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09
A074752-003CARTIA XTDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09
A074752-004CARTIA XTDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A074752-001AB3
A074752-002AB3
A074752-003AB3
A074752-004AB3

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 22:54:322026-06A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09a50c72e98297…
2026-08-01 22:54:322026-06A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09a50c72e98297…
2026-08-01 22:54:322026-06A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09a50c72e98297…
2026-08-01 22:54:322026-06A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074752-001AB31a50c72e98297…
2026-08-01 22:54:322026-06A074752-002AB31a50c72e98297…
2026-08-01 22:54:322026-06A074752-003AB31a50c72e98297…
2026-08-01 22:54:322026-06A074752-004AB31a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cartia XTDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.2dc2b889-8443-4f7f-83be-86c68e1798042026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde671934-25a8-4df6-b7a1-97e0337e9e2b2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke02f5fad-6482-4d5d-91c5-0ae6b0ce15b82025-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752
CARTIA XTDILTIAZEM HYDROCHLORIDEDirectRxdbfda3a5-5602-6e47-e053-2995a90ac07b2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61ebbccf-eedf-453b-940e-dba67b7a5fefProduct name420260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740Product name120251124
f6700316-a6ba-5e59-3413-8ede05ae58b9Product name720250625
8615f7a1-1e8f-8281-8601-d7a637926d1fProduct name420250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308Product name220240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628Product name220240314
378290be-e30f-0e68-1201-165e93c337e8Product name320231212
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3051-0CartiaXT30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
50090-3051-1CartiaXT90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3051-0EA - Each50090-3051c99ad64a-1cd3-4ab0-9150-c67b9a6a5cf312019-05-02
50090-3051-1EA - Each50090-305191cc0175-1d68-42d4-802e-e0455d28cad812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3051CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20220208_795f516a-9fda-48ef-84a5-4e2e4ff7a756.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831226Cartia XT 120 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
831255Cartia XT 180 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83122624 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Cartia]SBD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83125524 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Cartia]SBD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83122624 HR Cartia 120 MG Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83125524 HR Cartia 180 MG Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
831226Cartia 120 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
831255Cartia 180 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3051-15009030510190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3051-1) 2014-11-280000-00-00NoNoCurrent