Gemcitabine
- Product NDC
- 0143-9342
- 11-digit product format
- 001439342
- Labeler code
- 0143
- Product ID
- 0143-9342_e9bd951d-0a47-409c-aa7c-2df9157d94e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemcitabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA213175
- Marketing category
- ANDA
- Marketing start
- 2025-10-17
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 38 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gemcitabine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GEMCITABINE HYDROCHLORIDE | 38 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | U347PV74IL |
| Rxcui | 1720960, 1720975, 1720977 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a2b7d477-0e35-4772-8a9d-99c71e3e210b | Product name | 2 | 20190614 |
| 4c31c9b8-06d5-4f83-9eb7-cd946af7067a | Product name | 5 | 20190612 |
| a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6 | Product name | 1 | 20180829 |
| d2980057-8cff-4896-979e-b4c394974cfd | Product name | 1 | 20170829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9342-01 | Gemcitabine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 4 | |
| 0143-9342-01 | Gemcitabine | 52.6 mL in 1 VIAL | INJECTION, SOLUTION | 52.6 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9342-01 | ML - Milliliter | 0143-9342 | 49f8f5ac-5b8f-4922-b7f9-19e245415e9a | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1720960 | gemcitabine 1 GM in 26.3 ML Injection | PSN | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720975 | gemcitabine 2 GM in 52.6 ML Injection | PSN | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720977 | gemcitabine 200 MG in 5.26 ML Injection | PSN | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720960 | 26.3 ML gemcitabine 38 MG/ML Injection | SCD | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720977 | 5.26 ML gemcitabine 38 MG/ML Injection | SCD | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720975 | 52.6 ML gemcitabine 38 MG/ML Injection | SCD | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720960 | gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML Injection | SY | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720975 | gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML Injection | SY | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720977 | gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML Injection | SY | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720960 | gemcitabine 1 GM per 26.3 ML Injection | SY | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720975 | gemcitabine 2 GM per 52.6 ML Injection | SY | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
| 1720977 | gemcitabine 200 MG per 5.26 ML Injection | SY | d80176fe-3e8b-48be-87c2-9c603013b3fa | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0143-9342-01 | 00143934201 | 1 VIAL in 1 CARTON (0143-9342-01) / 52.6 mL in 1 VIAL | 1 vial | 2025-10-17 | No | No | Current |