Amlodipine Besylate and Benazepril Hydrochloride
- Product NDC
- 63629-5366
- 11-digit product format
- 636295366
- Labeler code
- 63629
- Product ID
- 63629-5366_006af2f4-012f-433e-aead-4710a8a5ec95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077179
- Marketing category
- ANDA
- Marketing start
- 2011-07-20
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| 55bffd21-17e1-ff02-2e8f-1f9a532b9502 | Product name | 2 | 20150320 |
| 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 |
| b9fbc696-7d55-c52e-4f12-7e3d99cd2db4 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-5366-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-43c2-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. AMLODIPINE besylate and BENAZEPRIL hydrochloride capsules for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-5366-1 | Amlodipine Besylate and Benazepril Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | 1000 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-5366 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] | 1000 | Legacy NDC, 1 package rows | 20140709_180506ee-0d90-4399-bc7b-fb1489951551.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 898359 | amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral Capsule | PSN | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |
| 898359 | amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule | SCD | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |
| 898359 | amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral Capsule | SY | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |
| 898359 | Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule | SY | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 63629-5366-1 | 63629536601 | 30 in 1 BOTTLE | Historical |