FDA.reportPublic FDA data

Sdamlo

Product NDC
81279-135
11-digit product format
812790135
Labeler code
81279
Product ID
81279-135_4b0523be-cded-6306-e063-6394a90a8a12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine
Dosage form
SOLUTION
Route
ORAL
Labeler
Pangea Pharmaceuticals, LLC
Application
NDA219531
Marketing category
NDA
Marketing start
2026-02-05
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/10mg
Pharmacologic classes
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
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219531-001SDAMLOAMLODIPINE BESYLATEEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24
N219531-002SDAMLOAMLODIPINE BESYLATEEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24
N219531-003SDAMLOAMLODIPINE BESYLATEEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24

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 22:38:342026-08N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-2484e616aacf4f…
2026-09-14 22:38:342026-08N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-2484e616aacf4f…
2026-09-14 22:38:342026-08N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-2484e616aacf4f…
2026-08-18 06:07:402026-07N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD2025-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD2025-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD2025-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-246a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

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
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81279-135-10Sdamlo10 in 1 CARTONSOLUTION104
81279-135-10Sdamlo10 mg in 1 BOTTLESOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81279-135-10EA - Each81279-135e7ff4433-bd74-421f-8520-44d6b857d66a12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2726068amLODIPine 10 MG Powder for Oral SolutionPSN886a7f97-60a4-4206-a6c7-5206069ed4874
2726058amLODIPine 2.5 MG Powder for Oral SolutionPSN886a7f97-60a4-4206-a6c7-5206069ed4874
2726065amLODIPine 5 MG Powder for Oral SolutionPSN886a7f97-60a4-4206-a6c7-5206069ed4874
2726070Sdamlo 10 MG Powder for Oral SolutionPSN886a7f97-60a4-4206-a6c7-5206069ed4874
2726064Sdamlo 2.5 MG Powder for Oral SolutionPSN886a7f97-60a4-4206-a6c7-5206069ed4874
2726067Sdamlo 5 MG Powder for Oral SolutionPSN886a7f97-60a4-4206-a6c7-5206069ed4874
2726070amlodipine 10 MG Powder for Oral Solution [Sdamlo]SBD886a7f97-60a4-4206-a6c7-5206069ed4874
2726064amlodipine 2.5 MG Powder for Oral Solution [Sdamlo]SBD886a7f97-60a4-4206-a6c7-5206069ed4874
2726067amlodipine 5 MG Powder for Oral Solution [Sdamlo]SBD886a7f97-60a4-4206-a6c7-5206069ed4874
2726068amlodipine 10 MG Powder for Oral SolutionSCD886a7f97-60a4-4206-a6c7-5206069ed4874
2726058amlodipine 2.5 MG Powder for Oral SolutionSCD886a7f97-60a4-4206-a6c7-5206069ed4874
2726065amlodipine 5 MG Powder for Oral SolutionSCD886a7f97-60a4-4206-a6c7-5206069ed4874
2726068amlodipine 10 MG (as amlodipine besylate 13.88 MG) Powder for Oral SolutionSY886a7f97-60a4-4206-a6c7-5206069ed4874
2726058amlodipine 2.5 MG (as amlodipine besylate 3.47 MG) Powder for Oral SolutionSY886a7f97-60a4-4206-a6c7-5206069ed4874
2726065amlodipine 5 MG (as amlodipine besylate 6.94 MG) Powder for Oral SolutionSY886a7f97-60a4-4206-a6c7-5206069ed4874
2726070Sdamlo 10 MG Powder for Oral SolutionSY886a7f97-60a4-4206-a6c7-5206069ed4874
2726064Sdamlo 2.5 MG Powder for Oral SolutionSY886a7f97-60a4-4206-a6c7-5206069ed4874
2726067Sdamlo 5 MG Powder for Oral SolutionSY886a7f97-60a4-4206-a6c7-5206069ed4874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81279-135-108127901351010 BOTTLE in 1 CARTON (81279-135-10) / 10 mg in 1 BOTTLE10 bottle2026-02-05NoNoHistorical