Neulasta
- Product NDC
- 55513-190
- 11-digit product format
- 555130190
- Labeler code
- 55513
- Product ID
- 55513-190_0a35b49f-339b-4651-829a-4e84fb3a0759
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegfilgrastim
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Amgen, Inc
- Application
- BLA125031
- Marketing category
- BLA
- Marketing start
- 2002-04-01
- Substance
- PEGFILGRASTIM
- Active strength
- 6 mg/.6mL
- Pharmacologic classes
- Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Neulasta
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PEGFILGRASTIM | 6 mg/.6mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 3A58010674 |
| Rxcui | 727539, 727542, 2549331, 2549333, 2739503, 2739504 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7979a9c8-e75a-40a9-87cc-a5f08355aaef | Product name | 1 | 20230626 |
| c3bb58c9-5c71-4b39-a70d-70acbffd3efe | Product name | 1 | 20230127 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 4217ae0d-ff4c-46f5-9e69-8cb4b72b3e37 | Product name | 1 | 20150402 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55513-190-01 | Neulasta | 1 in 1 CARTON | INJECTION | 1 | 159 | |
| 55513-190-01 | Neulasta | 0.6 mL in 1 SYRINGE | INJECTION | 0.6 | 159 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55513-190-01 | ML - Milliliter | 55513-190 | 4b57393a-562d-494f-a2a0-bc461177834f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PEGFILGRASTIM | ACTIVE INGREDIENT | 3A58010674 | NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC] | 126 | |
| PEGFILGRASTIM | ACTIVE MOIETY | 3A58010674 | NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC] | 126 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC] | 126 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC] | 126 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC] | 126 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC] | 126 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEULASTA (PEGFILGRASTIM) KIT NEULASTA (PEGFILGRASTIM) INJECTION [AMGEN INC] | 126 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2739504 | Neulasta 4 MG in 0.4 ML Injection | PSN | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 727542 | Neulasta 6 MG in 0.6 ML Prefilled Syringe | PSN | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2549333 | Neulasta Onpro 6 MG in 0.6 mL Injection | PSN | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2739503 | pegfilgrastim 4 MG in 0.4 ML Injection | PSN | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2549331 | pegfilgrastim 6 MG in 0.6 mL On-body Injection | PSN | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 727539 | pegfilgrastim 6 MG in 0.6 ML Prefilled Syringe | PSN | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2739504 | 0.4 ML pegfilgrastim 10 MG/ML Injection [Neulasta] | SBD | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2549333 | 0.6 ML pegfilgrastim 10 MG/ML Injection [Neulasta] | SBD | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 727542 | 0.6 ML pegfilgrastim 10 MG/ML Prefilled Syringe [Neulasta] | SBD | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2739503 | 0.4 ML pegfilgrastim 10 MG/ML Injection | SCD | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2549331 | 0.6 ML pegfilgrastim 10 MG/ML Injection | SCD | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 727539 | 0.6 ML pegfilgrastim 10 MG/ML Prefilled Syringe | SCD | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 727542 | 0.6 ML Neulasta 10 MG/ML Prefilled Syringe | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2739504 | Neulasta 4 MG per 0.4 ML Injection | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 727542 | Neulasta 6 MG per 0.6 ML Prefilled Syringe | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2549333 | Neulasta Onpro 6 MG per 0.6 ML Injection | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2549331 | pegfilgrastim 10 MG/ML per 0.6 ML On-body Injection | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2739503 | pegfilgrastim 4 MG per 0.4 ML Injection | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 2549331 | pegfilgrastim 6 MG per 0.6 ML On-body Injection | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
| 727539 | pegfilgrastim 6 MG per 0.6 ML Prefilled Syringe | SY | fdfe5d72-6b80-435a-afa4-c5d74dd852ce | 159 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55513-190-01 | 55513019001 | 1 SYRINGE in 1 CARTON (55513-190-01) / .6 mL in 1 SYRINGE | 1 syringe | 2002-04-01 | 0000-00-00 | No | No | Current |