Home NDC 81279-133 Sdamlo
Product NDC 81279-133
11-digit product format 812790133
Labeler code 81279
Product ID 81279-133_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 2.5 mg/2.5mg
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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219531-001 SDAMLO AMLODIPINE BESYLATE EQ 2.5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 N219531-002 SDAMLO AMLODIPINE BESYLATE EQ 5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 N219531-003 SDAMLO AMLODIPINE BESYLATE EQ 10MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N219531-001 SDAMLO EQ 2.5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219531-002 SDAMLO EQ 5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219531-003 SDAMLO EQ 10MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219531-001 SDAMLO EQ 2.5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219531-002 SDAMLO EQ 5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219531-003 SDAMLO EQ 10MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219531-001 SDAMLO EQ 2.5MG BASE/BOT FOR SOLUTION / ORAL RLD 2025-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219531-002 SDAMLO EQ 5MG BASE/BOT FOR SOLUTION / ORAL RLD 2025-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219531-003 SDAMLO EQ 10MG BASE/BOT FOR SOLUTION / ORAL RLD 2025-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219531-001 SDAMLO EQ 2.5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219531-002 SDAMLO EQ 5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219531-003 SDAMLO EQ 10MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219531-001 SDAMLO EQ 2.5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219531-002 SDAMLO EQ 5MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219531-003 SDAMLO EQ 10MG BASE/BOT FOR SOLUTION / ORAL RLD, RS 2025-07-24 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Sdamlo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 2.5 mg/2.5mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2726058 Internal RxNorm lookup 2726064 Internal RxNorm lookup 2726065 Internal RxNorm lookup 2726067 Internal RxNorm lookup 2726068 Internal RxNorm lookup 2726070 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81279-133-10 Sdamlo 2.5 mg in 1 BOTTLE SOLUTION 2.5 4 81279-133-10 Sdamlo 10 in 1 CARTON SOLUTION 10 4
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81279-133-10 81279013310 10 BOTTLE in 1 CARTON (81279-133-10) / 2.5 mg in 1 BOTTLE 10 bottle 2026-02-05 No No Current