Esmolol Hydrochloride in Water
- Product NDC
- 44567-812
- 11-digit product format
- 445670812
- Labeler code
- 44567
- Product ID
- 44567-812_0aee9e81-c563-4207-9157-8bf70a163010
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esmolol Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- WG Critical Care, LLC
- Application
- NDA205703
- Marketing category
- NDA
- Marketing start
- 2017-12-04
- Substance
- ESMOLOL HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | |
| N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | |
| N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | |
| N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | |
| N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | bb7c543d1eb4… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esmolol Hydrochloride in Water
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESMOLOL HYDROCHLORIDE | 20 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V05260LC8D | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60b10020-f802-4fef-a487-0f11eca246c5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ab3d10ea-fe48-4811-8e72-bb51600b35f9 | Product name | 5 | 20230103 |
| 9cb9173b-3912-466b-8256-366e71d49fce | Product name | 1 | 20190402 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44567-812-10 | Esmolol Hydrochloride in Water | 100 mL in 1 BAG | INJECTION | 100 | 10 | |
| 44567-812-10 | Esmolol Hydrochloride in Water | 10 in 1 CARTON | INJECTION | 10 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 44567-812-10 | ML - Milliliter | 44567-812 | c5309b17-bb75-4113-acae-a0b94b03dbf4 | 1 | 2018-03-08 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Esmolol Hydrochloride in Water | ESMOLOL HYDROCHLORIDE | WG Critical Care, LLC | 60b10020-f802-4fef-a487-0f11eca246c5 | 2024-05-31 | Warnings, Adverse reactions | 205703 NDA205703 44567-812 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 979432 | esmolol HCl 2000 MG in 100 ML Injection | PSN | 60b10020-f802-4fef-a487-0f11eca246c5 | 10 |
| 1736541 | esmolol HCl 2500 MG in 250 ML Injection | PSN | 60b10020-f802-4fef-a487-0f11eca246c5 | 10 |
| 979432 | 100 ML esmolol hydrochloride 20 MG/ML Injection | SCD | 60b10020-f802-4fef-a487-0f11eca246c5 | 10 |
| 1736541 | 250 ML esmolol hydrochloride 10 MG/ML Injection | SCD | 60b10020-f802-4fef-a487-0f11eca246c5 | 10 |
| 979432 | esmolol HCl 2000 MG per 100 ML Injection | SY | 60b10020-f802-4fef-a487-0f11eca246c5 | 10 |
| 1736541 | esmolol HCl 2500 MG per 250 ML Injection | SY | 60b10020-f802-4fef-a487-0f11eca246c5 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 44567-812-10 | 44567081210 | 10 BAG in 1 CARTON (44567-812-10) / 100 mL in 1 BAG | 10 bag | 2017-12-04 | 0000-00-00 | No | No | Current |