Edarbyclor
- Product NDC
- 60631-425
- 11-digit product format
- 606310425
- Labeler code
- 60631
- Product ID
- 60631-425_26b92714-c5ea-943d-e063-6394a90a8341
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azilsartan kamedoxomil and chlorthalidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
- Application
- NDA202331
- Marketing category
- NDA
- Marketing start
- 2013-02-01
- Substance
- AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
- Active strength
- 40; 25 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Edarbyclor
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AZILSARTAN KAMEDOXOMIL | 40 mg/1 |
| CHLORTHALIDONE | 25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q0MQD1073Q |
| Rxcui | 1235144, 1235150, 1235151, 1235157 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 83fe98fe-2a14-448c-9029-41f7600d1b0a | Product name | 1 | 20260105 |
| 0450926f-f624-49c2-83be-42807e8fbcd5 | Product name | 1 | 20251113 |
| 8525e779-537f-e5cc-2515-089ecce5f50f | Product name | 9 | 20221128 |
| faf41ef3-b4b3-a29e-3b26-07c3009003bf | Product name | 5 | 20220517 |
| 9c73251d-aa60-4cfe-993e-64d90dc1df32 | Product name | 1 | 20201015 |
| 3f5e2da3-8b99-f714-3261-2c998ee07b05 | Product name | 1 | 20140508 |
| 7667d8e2-e5be-36e1-4de7-231aa7fdaf5c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60631-425-30 | Edarbyclor | 30 in 1 BOTTLE | TABLET | 30 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60631-425-30 | EA - Each | 60631-425 | 435432a5-0147-461b-80c1-db004891470d | 1 | 2015-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60631-425 | EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE) TABLET [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)] | 18 | Current NDC, Legacy NDC, 1 package rows | 20241115_e60f795b-fce3-4361-aa03-f143451689d1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1235144 | azilsartan medoxomil 40 MG / chlorthalidone 12.5 MG Oral Tablet | PSN | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235151 | azilsartan medoxomil 40 MG / chlorthalidone 25 MG Oral Tablet | PSN | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235150 | edarbyclor 40 MG / 12.5 MG Oral Tablet | PSN | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235157 | edarbyclor 40 MG / 25 MG Oral Tablet | PSN | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235150 | azilsartan medoxomil 40 MG / chlorthalidone 12.5 MG Oral Tablet [Edarbyclor] | SBD | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235157 | azilsartan medoxomil 40 MG / chlorthalidone 25 MG Oral Tablet [Edarbyclor] | SBD | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235144 | azilsartan medoxomil 40 MG / chlorthalidone 12.5 MG Oral Tablet | SCD | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235151 | azilsartan medoxomil 40 MG / chlorthalidone 25 MG Oral Tablet | SCD | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235150 | Edarbyclor 40/12.5 (azilsartan medoxomil (azilsartan kamedoxomil 42.68 MG) / chlorthalidone) Oral Tablet | SY | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235150 | Edarbyclor 40/12.5 Oral Tablet | SY | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235157 | Edarbyclor 40/25 (azilsartan medoxomil (azilsartan kamedoxomil 42.68 MG) / chlorthalidone) Oral Tablet | SY | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
| 1235157 | Edarbyclor 40/25 Oral Tablet | SY | e60f795b-fce3-4361-aa03-f143451689d1 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60631-425-30 | 60631042530 | 30 TABLET in 1 BOTTLE (60631-425-30) | 30 tablet | 2013-02-01 | 0000-00-00 | No | No | Current |