Cardene IV
- Product NDC
- 10122-314
- Requested package NDC
- 10122-314-10
- 11-digit product format
- 101220314
- Labeler code
- 10122
- Product ID
- 10122-314_35a66ebb-329c-49ad-a047-9c0bf15e8028
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nicardipine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Chiesi USA, Inc.
- Application
- NDA019734
- Marketing category
- NDA
- Marketing start
- 1992-01-30
- Marketing end
- 2022-06-30
- Substance
- NICARDIPINE HYDROCHLORIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 10122-314 | 10122-314-10 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019734-001 | CARDENE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-01-30 |
| N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | |
| N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 |
| N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 |
| N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019734-001 | AP |
| N019734-003 | AP |
| N019734-004 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N019734-002 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | |
| N019734-002 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | |
| N019734-002 | 7659291 | 2027-04-18 | U-1029 | ||
| N019734-002 | 8455524 | 2027-04-18 | U-1029 | 2013-06-27 | |
| N019734-002 | 7612102 | 2027-12-26 | Drug product | ||
| N019734-002 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | |
| N019734-003 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | |
| N019734-003 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | |
| N019734-003 | 7659291 | 2027-04-18 | U-1029 | ||
| N019734-003 | 8455524 | 2027-04-18 | U-1029 | ||
| N019734-003 | 7612102 | 2027-12-26 | Drug product | ||
| N019734-003 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | |
| N019734-004 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | |
| N019734-004 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | |
| N019734-004 | 7659291 | 2027-04-18 | U-1029 | ||
| N019734-004 | 8455524 | 2027-04-18 | U-1029 | ||
| N019734-004 | 7612102 | 2027-12-26 | Drug product | ||
| N019734-004 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | |
| N019734-005 | 7659291 | 2027-04-18 | U-1029 | ||
| N019734-005 | 8455524 | 2027-04-18 | U-1029 | ||
| N019734-005 | 7612102 | 2027-12-26 | Drug product | ||
| N019734-005 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1992-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019734-001 | CARDENE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019734-002 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | RLD, RS | 2008-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019734-003 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-07-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019734-004 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2008-11-07 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019734-005 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | RLD | 2008-11-07 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019734-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019734-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019734-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019734-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019734-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019734-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019734-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019734-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019734-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019734-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019734-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019734-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019734-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019734-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019734-004 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019734-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019734-004 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019734-003 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019734-004 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019734-003 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019734-004 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019734-003 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019734-004 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019734-003 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019734-004 | AP | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019734-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019734-003 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019734-004 | AP | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019734-002 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-002 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-002 | 7659291 | 2027-04-18 | U-1029 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-002 | 8455524 | 2027-04-18 | U-1029 | 2013-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-002 | 7612102 | 2027-12-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-002 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | 7659291 | 2027-04-18 | U-1029 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | 8455524 | 2027-04-18 | U-1029 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | 7612102 | 2027-12-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-003 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | 7659291 | 2027-04-18 | U-1029 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | 8455524 | 2027-04-18 | U-1029 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | 7612102 | 2027-12-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-004 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019734-005 | 7659291 | 2027-04-18 | U-1029 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-005 | 8455524 | 2027-04-18 | U-1029 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-005 | 7612102 | 2027-12-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019734-005 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-002 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-002 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-002 | 7659291 | 2027-04-18 | U-1029 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-002 | 8455524 | 2027-04-18 | U-1029 | 2013-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-002 | 7612102 | 2027-12-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-002 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | 7659291 | 2027-04-18 | U-1029 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | 8455524 | 2027-04-18 | U-1029 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | 7612102 | 2027-12-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-003 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | 10758616 | 2027-04-18 | Drug product | 2020-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | 11547758 | 2027-04-18 | U-1029 | 2023-02-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | 7659291 | 2027-04-18 | U-1029 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | 8455524 | 2027-04-18 | U-1029 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | 7612102 | 2027-12-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019734-004 | 9364564 | 2027-12-26 | Drug product | 2016-07-08 | 31067a03dcf5… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 31746078-c5c3-4387-a2ed-bd3c8b244c53 | Product name | 2 | 20250325 |
| 037c6bd8-1c81-7b8c-8280-c83d993a1f03 | Product name | 2 | 20250203 |
| c9eb0343-053f-7f78-730f-1be02ab91c6c | Product name | 5 | 20250130 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | ACTIVE INGREDIENT | K5BC5011K3 | CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] | 6 | |
| NICARDIPINE | ACTIVE MOIETY | CZ5312222S | CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] | 6 | |
| DEXTROSE MONOHYDRATE | INACTIVE INGREDIENT | LX22YL083G | CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] | 6 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] | 6 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] | 6 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | a3e33add-0d09-423a-9109-42e5ba7148d5 | 2026-04-13 | Warnings, Adverse reactions | 019734 NDA019734 |
| Cardene IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | 5499cfac-9147-4d5d-a8cb-f8d64f1481af | 2026-04-13 | Warnings, Adverse reactions | 019734 NDA019734 |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e | 2026-03-27 | Warnings, Adverse reactions | 019734 NDA019734 |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | 5749599d-ff2a-42e4-aa72-cd25013feee8 | 2025-12-29 | Warnings, Adverse reactions | 019734 NDA019734 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858599 | niCARdipine HCl 20 MG in 200 ML Injection | PSN | a14a6a4d-232b-634f-e053-2a95a90a2323 | 1 |
| 858599 | 200 ML nicardipine hydrochloride 0.1 MG/ML Injection | SCD | a14a6a4d-232b-634f-e053-2a95a90a2323 | 1 |
| 858599 | nicardipine hydrochloride 20 MG per 200 ML Injection | SY | a14a6a4d-232b-634f-e053-2a95a90a2323 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10122-314-10 | 10122031410 | 10 CARTON in 1 BOX (10122-314-10) > 1 BAG in 1 CARTON (10122-314-01) > 200 mL in 1 BAG | 10 carton | 1992-01-30 | 2022-06-30 | No | No | Current |