NDC 68001-282-22 - Gemcitabine Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68001-282
- Requested NDC
- 68001-282-22
- Package NDCs from labels
- 68001-282-22, 68001-282-25, 68001-282-23, 68001-282-26, 68001-282-24, 68001-282-27
- Manufacturer
- BluePoint Laboratories | Accord Healthcare Inc. | Intas Pharmaceuticals Limited
- Effective date
- 2021-07-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Gemcitabine Hydrochloride - BluePoint Laboratories | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | BluePoint Laboratories | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 2021-07-05 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-282-22 | EA - Each | 68001-282 | aeb0c7ed-5d8a-4890-96a6-6d5d9953a6e7 | 1 | 2016-07-19 |
| 68001-282-23 | EA - Each | 68001-282 | 575b59c6-8897-475d-bfdc-f976c8da75aa | 1 | 2016-07-19 |
| 68001-282-24 | EA - Each | 68001-282 | 19e24296-3ad9-4869-b81b-042dddf1e9b8 | 1 | 2016-07-19 |
| 68001-282-25 | EA - Each | 68001-282 | 10a4f7e1-a20d-4fe1-ad2d-512744533ed4 | 1 | 2016-07-19 |
| 68001-282-26 | EA - Each | 68001-282 | 9d5e60fc-c391-43a6-b434-26e3a0e5ecb4 | 1 | 2016-07-19 |
| 68001-282-27 | EA - Each | 68001-282 | c193ed00-cacc-4fcf-ae22-4c7668199215 | 1 | 2016-07-19 |
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 |
|---|---|---|---|---|---|---|
| AVGEMSI | GEMCITABINE | Avyxa Pharma, LLC | e11eeff7-bcaf-4bf1-8da8-88138e01af84 | 2026-07-27 | Warnings, Adverse reactions | U347PV74IL |
| Gemcitabine | GEMCITABINE | Hospira, Inc. | dc02a23b-3ff9-4441-aa91-8e9e629a7315 | 2026-04-27 | Warnings, Adverse reactions | U347PV74IL |
| Gemcitabine | GEMCITABINE | Hospira, Inc. | e18ed1cb-7dd0-4001-bfda-17d1f4587fb8 | 2026-04-27 | Warnings, Adverse reactions | U347PV74IL |
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | 3OWL53L36A |
| Sodium Acetate | SODIUM ACETATE | MILLA PHARMACEUTICALS INC. | 1ea1466d-a492-4056-e063-6394a90a80bf | 2026-01-07 | Warnings, Adverse reactions | 4550K0SC9B |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 8f8f53e3-fe31-e7b5-e053-2995a90a710d | 2025-11-14 | Warnings | 3OWL53L36A |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | 3OWL53L36A |
| Mannitol | MANNITOL | ProPharma Distribution | 430669d7-9ad1-9a04-e063-6394a90ababb | 2025-11-07 | Warnings, Adverse reactions | 3OWL53L36A |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | 3OWL53L36A |
| Gemcitabine | GEMCITABINE | Hikma Pharmaceuticals USA Inc. | d80176fe-3e8b-48be-87c2-9c603013b3fa | 2025-10-24 | Warnings, Adverse reactions | U347PV74IL |
| Perikabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | c2eb5522-8572-45f4-869d-42f9fd251bb6 | 2025-09-15 | Warnings, Adverse reactions | 4550K0SC9B |
| Kabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | afeb4837-a759-4484-a76e-e04611c459e7 | 2025-09-11 | Warnings, Adverse reactions | 4550K0SC9B |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| Gemcitabine | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | c0b1b715-9ff8-43ca-9e49-465f1f380084 | 2025-07-23 | Warnings, Adverse reactions | U347PV74IL |
| InterSol | PLATELET ADDITIVE 3 | Fenwal, Inc. | 17dec820-1b57-4ac9-82a8-419cab664a2f | 2025-06-27 | Warnings, Adverse reactions | 4550K0SC9B |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| GEMCITABINE | GEMCITABINE HYDROCHLORIDE | NorthStar Rx LLC | 5af49a48-f1c0-467d-b5da-ac9f1ae8e34c | 2025-02-03 | Warnings, Adverse reactions | U347PV74IL |
| Gemcitabine | GEMCITABINE | Sagent Pharmaceuticals | 22af3507-4b4f-4cad-9d61-89ffc4aabbc7 | 2025-02-03 | Warnings, Adverse reactions | U347PV74IL |
| GEMCITABINE | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | a5949d02-29eb-4626-ad35-b7614bb0fa95 | 2025-01-29 | Warnings, Adverse reactions | U347PV74IL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.