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 |
|---|---|---|---|---|---|---|
| Sodium Acetate | SODIUM ACETATE | MILLA PHARMACEUTICALS INC. | 1ea04916-78e5-4651-e063-6394a90ac4be | 2025-01-16 | Warnings, Adverse reactions | 4550K0SC9B |
| Gemcitabine hydrochloride | GEMCITABINE HYDROCHLORIDE | Teyro Labs Private Limited | a6ddaa2f-4c17-430f-a7cd-96b6662923f6 | 2025-01-09 | Warnings, Adverse reactions | U347PV74IL |
| Gemcitabine | GEMCITABINE HYDROCHLORIDE | Mylan Institutional LLC | 06dd9d40-74fc-4409-93b1-a46be7126331 | 2024-11-11 | Warnings, Adverse reactions | U347PV74IL |
| Plasma-Lyte 148 (pH 7.4) | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | fe935c8d-f42d-42e4-8665-0dc66829f231 | 2024-11-08 | 4550K0SC9B | |
| GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | c550dd16-a5e8-44be-87f2-210c15bbb513 | 2024-10-14 | Warnings, Adverse reactions | U347PV74IL |
| SODIUM ACETATE | SODIUM ACETATE | Fresenius Kabi USA, LLC | d7fabf08-d4e0-4bb5-8416-2e8ffe27c04b | 2024-10-11 | Warnings, Adverse reactions | 4550K0SC9B |
| gemcitabine | GEMCITABINE | Dr. Reddy's Laboratories Limited | eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4 | 2024-09-09 | Warnings, Adverse reactions | U347PV74IL |
| gemcitabine hydrochloride | GEMCITABINE HYDROCHLORIDE | Gland Pharma Limited | 9f8fe5ba-943f-4f0a-9618-6083101faa28 | 2024-09-06 | Warnings, Adverse reactions | U347PV74IL |
| Gemcitabine | GEMCITABINE | Hospira, Inc. | d16907e7-a8c8-4039-ace4-cf4e24ba68c0 | 2024-08-16 | Warnings, Adverse reactions | U347PV74IL |
| GEMCITABINE | GEMCITABINE | Hospira, Inc. | a625c92b-c569-4b98-8d2e-2b3f5e12b34f | 2024-08-16 | Warnings, Adverse reactions | U347PV74IL |
| Gemcitabine | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 73ae04d8-38f9-4d3d-b0c2-71d22af1fc86 | 2024-08-05 | Warnings, Adverse reactions | U347PV74IL |
| Isolyte P in Dextrose | DEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASIC | B. Braun Medical Inc. | 4ea4397c-2fa4-4670-91e6-21ae498c88f7 | 2024-06-24 | Warnings, Adverse reactions | 4550K0SC9B |
| Balanced Salt | SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE | B. Braun Medical Inc. | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2024-03-13 | Warnings, Adverse reactions | 4550K0SC9B |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
| BSS | BALANCED SALT SOLUTION | Alcon Laboratories, Inc. | 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea | 2024-01-25 | Warnings, Adverse reactions | 4550K0SC9B |
| BSS | BALANCED SALT SOLUTION | Alcon Laboratories, Inc. | 28488c7b-cf6a-4a03-916f-cc66b3afdc57 | 2023-12-14 | Warnings, Adverse reactions | 4550K0SC9B |
| Isolyte S pH 7.4 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE | B. Braun Medical Inc. | 150437b6-320e-4c69-a434-2a26a1f0b2e4 | 2023-10-06 | Warnings, Adverse reactions | 4550K0SC9B |
| Physiolyte | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 2023-09-26 | Warnings, Adverse reactions | 4550K0SC9B |
| Natrum Aceticum | NATRUM ACETICUM | Hahnemann Laboratories, INC. | 04cdea6c-8348-d855-e063-6294a90a6660 | 2023-09-07 | 4550K0SC9B | |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.