Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
63629-1454
Requested package NDC
63629-1454-3
11-digit product format
636291454
Labeler code
63629
Product ID
63629-1454_ee0407b7-bc98-2efb-e053-2995a90a9e79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077183
Marketing category
ANDA
Marketing start
2010-04-19
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-145463629-1454-3DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15
A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15
A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15
A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077183-001AB
A077183-002AB
A077183-003AB
A077183-004AB

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-08-18 06:07:402026-07A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077183-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077183-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077183-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077183-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077183-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077183-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077183-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1454-1EA - Each63629-14542aa11ced-eafd-4c86-892d-9fbe1ef2535b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
AMLODIPINEACTIVE MOIETY1J444QC288AMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
BENAZEPRILACTIVE MOIETYUDM7Q7QWP8AMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
crospovidoneINACTIVE INGREDIENT68401960MKAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
gelatinINACTIVE INGREDIENT2G86QN327LAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLOBENZ CAPSULE [BRYANT RANCH PREPACK]2

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCfa153720-b24c-60d0-e053-6294a90a97d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC106c08c2-90eb-6bc0-e063-6294a90a5a232025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions7a75935a-31af-4571-b7d9-8c297a635b572025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedca014f06-982c-6fe1-9948-a3701dd35d342022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1454-36362914540360 CAPSULE in 1 BOTTLE (63629-1454-3) 60 capsule2011-01-210000-00-00NoNoCurrent