FDA.reportPublic FDA data

Amlodipine and Olmesartan Medoxomil

Product NDC
31722-447
11-digit product format
317220447
Labeler code
31722
Product ID
31722-447_313d90a7-6e92-d956-e063-6394a90a3d6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA209591
Marketing category
ANDA
Marketing start
2025-02-14
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
10; 20 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 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
A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14
A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14
A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14
A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209591-001AB
A209591-002AB
A209591-003AB
A209591-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209591-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209591-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209591-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A209591-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A209591-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209591-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209591-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-004AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-004AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine and Olmesartan Medoxomil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1
OLMESARTAN MEDOXOMIL20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864V2Q084HInternal UNII lookup
6M97XTV3HDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
730861Internal RxNorm lookup
730866Internal RxNorm lookup
730869Internal RxNorm lookup
730872Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99865c67-5475-4e60-98d5-a8fa850fe9baAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-447-30Amlodipine and Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED301
31722-447-90Amlodipine and Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-447-30EA - Each31722-4475fb644c2-f98d-4755-81c8-d6bada83614612025-09-12
31722-447-90EA - Each31722-447dccc523c-0dc0-4fb9-91a6-e96b77df059d12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-447AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED AMLODIPINE AND OLMESARTAN MEDOXOMIL (AAMLODIPINE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250327_99865c67-5475-4e60-98d5-a8fa850fe9ba.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILCamber Pharmaceuticals, Inc.99865c67-5475-4e60-98d5-a8fa850fe9ba2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209591
application number: ANDA209591
ndc (product): 31722-447

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730861amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral TabletPSN99865c67-5475-4e60-98d5-a8fa850fe9ba1
730866amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral TabletPSN99865c67-5475-4e60-98d5-a8fa850fe9ba1
730869amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral TabletPSN99865c67-5475-4e60-98d5-a8fa850fe9ba1
730872amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral TabletPSN99865c67-5475-4e60-98d5-a8fa850fe9ba1
730861amlodipine 10 MG / olmesartan medoxomil 20 MG Oral TabletSCD99865c67-5475-4e60-98d5-a8fa850fe9ba1
730866amlodipine 10 MG / olmesartan medoxomil 40 MG Oral TabletSCD99865c67-5475-4e60-98d5-a8fa850fe9ba1
730869amlodipine 5 MG / olmesartan medoxomil 20 MG Oral TabletSCD99865c67-5475-4e60-98d5-a8fa850fe9ba1
730872amlodipine 5 MG / olmesartan medoxomil 40 MG Oral TabletSCD99865c67-5475-4e60-98d5-a8fa850fe9ba1
730861amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY99865c67-5475-4e60-98d5-a8fa850fe9ba1
730866amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY99865c67-5475-4e60-98d5-a8fa850fe9ba1
730869amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY99865c67-5475-4e60-98d5-a8fa850fe9ba1
730872amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY99865c67-5475-4e60-98d5-a8fa850fe9ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-447-303172204473030 TABLET, FILM COATED in 1 BOTTLE (31722-447-30) 2025-02-14NoNoCurrent
31722-447-903172204479090 TABLET, FILM COATED in 1 BOTTLE (31722-447-90) 2025-02-14NoNoCurrent