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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sdamlo
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 2.5 mg/2.5mg |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 864V2Q084H |
| Rxcui | 2726058, 2726064, 2726065, 2726067, 2726068, 2726070 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| c19ec24d-2c40-4b8d-7c20-500ffa3660a1 | Product name | 3 | 20260303 |
| b15e9aa6-d523-ca97-480e-570e0543a342 | Product name | 4 | 20251024 |
| 265792b3-b999-c010-7364-a7db20b9d4d9 | Product name | 5 | 20250515 |
| 14c2c15b-f823-4ada-a40e-a440544294dc | Product name | 1 | 20221207 |
| a72887ef-d675-499f-af4b-78688f6855cd | Product name | 1 | 20191002 |
| a4484670-2869-6416-f6ff-03b1b3cbd1b0 | Product name | 2 | 20190415 |
| 4a27501f-a987-48a5-99b4-e983d4744d76 | Product name | 7 | 20181211 |
| 18600d07-613d-bf9c-2711-fe40c06f3393 | Product name | 5 | 20180703 |
| bded1554-44de-900a-5297-403365d6d4b2 | Product name | 3 | 20170110 |
| 1f1c6e4b-bbad-4649-afd1-7a1d671db4b1 | Product name | 1 | 20150316 |
| 63ab5fbf-2a6b-c41d-051a-39e845d718b1 | Product name | 1 | 20140508 |
| 7613b1a5-acb6-4e5e-6048-c44deeeb1212 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2726068 | amLODIPine 10 MG Powder for Oral Solution | PSN | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726058 | amLODIPine 2.5 MG Powder for Oral Solution | PSN | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726065 | amLODIPine 5 MG Powder for Oral Solution | PSN | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726070 | Sdamlo 10 MG Powder for Oral Solution | PSN | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726064 | Sdamlo 2.5 MG Powder for Oral Solution | PSN | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726067 | Sdamlo 5 MG Powder for Oral Solution | PSN | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726070 | amlodipine 10 MG Powder for Oral Solution [Sdamlo] | SBD | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726064 | amlodipine 2.5 MG Powder for Oral Solution [Sdamlo] | SBD | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726067 | amlodipine 5 MG Powder for Oral Solution [Sdamlo] | SBD | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726068 | amlodipine 10 MG Powder for Oral Solution | SCD | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726058 | amlodipine 2.5 MG Powder for Oral Solution | SCD | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726065 | amlodipine 5 MG Powder for Oral Solution | SCD | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726068 | amlodipine 10 MG (as amlodipine besylate 13.88 MG) Powder for Oral Solution | SY | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726058 | amlodipine 2.5 MG (as amlodipine besylate 3.47 MG) Powder for Oral Solution | SY | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726065 | amlodipine 5 MG (as amlodipine besylate 6.94 MG) Powder for Oral Solution | SY | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726070 | Sdamlo 10 MG Powder for Oral Solution | SY | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726064 | Sdamlo 2.5 MG Powder for Oral Solution | SY | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
| 2726067 | Sdamlo 5 MG Powder for Oral Solution | SY | 886a7f97-60a4-4206-a6c7-5206069ed487 | 4 |
Packages#
| 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 |