GRANISETRON HYDROCHLORIDE
- Product NDC
- 55648-662
- 11-digit product format
- 556480662
- Labeler code
- 55648
- Product ID
- 55648-662_ac38ecc1-4f9d-4c72-88d5-c3caf3bf2b51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GRANISETRON HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- WOCKHARDT LIMITED
- Application
- ANDA078566
- Marketing category
- ANDA
- Marketing start
- 2008-03-03
- Marketing end
- 0000-00-00
- Substance
- GRANISETRON HYDROCHLORIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 product | product | 55648-662 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 55648-662 | 55648-662-01 | I | Inactivated by FDA | 2026-08-17 |
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 55648-662-01 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 55648-662-01 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078566-001 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 |
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 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | AP | 2008-02-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A078566-001 | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE / INJECTION | 2008-02-29 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-04 05:41 UTC | 2022-04 | A078566-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078566-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078566-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078566-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078566-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078566-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078566-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078566-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078566-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078566-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078566-001 | AP | 1 | ea99ee380514… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cfd5f35c-827b-432c-9fef-0869f8899c80 | Product name | 1 | 20260105 |
| bd0ef290-bb63-6056-ab17-adf968a44900 | Product name | 2 | 20170616 |
| d7be5b36-17f0-843a-22b1-df15cb96e594 | Product name | 3 | 20170616 |
| e5d20d92-e4d9-43c9-9475-8f368311d104 | Product name | 2 | 20170501 |
| 5a6fb99e-671a-4b1d-a9dc-1e7566682136 | Product name | 1 | 20160831 |
| 5c6cdff6-4525-6e4a-2964-09019d52be11 | Product name | 1 | 20140508 |
| ae524849-1812-2c3b-219e-58a687215e77 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55648-662-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0cea-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55648-662-01 | GRANISETRON HYDROCHLORIDE | 5 in 1 CARTON | INJECTION | 5 | 1 | |
| 55648-662-02 | GRANISETRON HYDROCHLORIDE | 1 in 1 CARTON | INJECTION | 1 | 1 | |
| 55648-662-02 | GRANISETRON HYDROCHLORIDE | 1 mL in 1 VIAL, SINGLE-USE | INJECTION | 1 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | ACTIVE INGREDIENT | 318F6L70J8 | GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| GRANISETRON | ACTIVE MOIETY | WZG3J2MCOL | GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GRANISETRON HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 543218 | granisetron HCl 0.1 MG in 1 ML Injection | PSN | a43da9a3-1997-40d9-8622-97490a5c0642 | 1 |
| 543218 | 1 ML granisetron 0.1 MG/ML Injection | SCD | a43da9a3-1997-40d9-8622-97490a5c0642 | 1 |
| 543218 | granisetron 0.1 MG per 1 ML Injection | SY | a43da9a3-1997-40d9-8622-97490a5c0642 | 1 |
| 543218 | granisetron 0.1 MG/ML (as granisetron HCl 0.112 MG/ML) Injection | SY | a43da9a3-1997-40d9-8622-97490a5c0642 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 55648-662-01 | 55648066201 | 5 in 1 CARTON | Historical |
| 55648-662-02 | 55648066202 | 1 in 1 CARTON | Historical |