FDA.reportPublic FDA data

Verapamil hydrochloride

Product NDC
68382-563
Requested package NDC
68382-563-05
11-digit product format
683820563
Labeler code
68382
Product ID
68382-563_ffca6bb5-e52a-426d-8f93-5e0e8da34eed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA219252
Marketing category
ANDA
Marketing start
2026-05-21
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
240 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219252-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2025-11-24
A219252-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2025-11-24
A219252-003VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2025-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A219252-001AB
A219252-002AB
A219252-003AB

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 22:54:322026-06A219252-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2025-11-24a50c72e98297…
2026-08-01 22:54:322026-06A219252-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2025-11-24a50c72e98297…
2026-08-01 22:54:322026-06A219252-003VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2025-11-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A219252-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A219252-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A219252-003AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEZydus Lifesciences Limited051392d3-8ec1-450c-8c38-791d4ef1a2db2026-04-09Exact identifier
application applno (ANDA): 219252
application number: ANDA219252
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.e19ab8d8-dae5-489d-9805-7e7407bea06d2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219252
application number: ANDA219252
ndc (package): 68382-563-05
ndc (product): 68382-563
ndc11 (package): 68382056305

Additional Listing Data#

Finished product
Yes
Brand name base
Verapamil hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V3888OEY5RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897640Internal RxNorm lookup
897649Internal RxNorm lookup
897659Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e19ab8d8-dae5-489d-9805-7e7407bea06dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea1f6fc8-bfc2-4421-a2eb-4e87c7c3e3c4Product name220230103
33ad674d-d105-6aa5-02fa-95ae4329b8cdProduct name220180809
3279bd6d-5b02-e60b-3857-c853a2deb2ddProduct name220170713
8ebb66e3-d7b3-f1e5-88aa-3369e64bb84aProduct name120140508
940a1faa-2df8-cc65-be37-1b97984b4ea3Product name120140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13Product name120140508
e2fcd66c-a043-3187-790d-b0342deb1149Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-563-01Verapamil hydrochloride100 in 1 BOTTLETABLET1001
68382-563-05Verapamil hydrochloride500 in 1 BOTTLETABLET5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897659verapamil HCl 120 MG Extended Release Oral TabletPSNe19ab8d8-dae5-489d-9805-7e7407bea06d1
897640verapamil HCl 180 MG Extended Release Oral TabletPSNe19ab8d8-dae5-489d-9805-7e7407bea06d1
897649verapamil HCl 240 MG Extended Release Oral TabletPSNe19ab8d8-dae5-489d-9805-7e7407bea06d1
897659verapamil hydrochloride 120 MG Extended Release Oral TabletSCDe19ab8d8-dae5-489d-9805-7e7407bea06d1
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDe19ab8d8-dae5-489d-9805-7e7407bea06d1
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCDe19ab8d8-dae5-489d-9805-7e7407bea06d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-563-0568382056305500 TABLET in 1 BOTTLE (68382-563-05) 500 tablet2026-05-21NoNoCurrent