NEUPOGEN
- Product NDC
- 55513-546
- 11-digit product format
- 555130546
- Labeler code
- 55513
- Product ID
- 55513-546_52115df1-de31-4353-a33b-5ca065af4e85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Filgrastim
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Amgen, Inc
- Application
- BLA103353
- Marketing category
- BLA
- Marketing start
- 1997-04-07
- Substance
- FILGRASTIM
- Active strength
- 480 ug/1.6mL
- 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
- NEUPOGEN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FILGRASTIM | 480 ug/1.6mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | PVI5M0M1GW |
| Rxcui | 727535, 727537, 727544, 727545, 1649944, 1649946, 1649963, 1649964 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0f366651-2cb6-4932-a760-2ae84fd8fbff | Product name | 1 | 20230703 |
| 3b1c6100-f679-4300-94a6-3b3fc05b0c44 | Product name | 1 | 20230110 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55513-546-01 | NEUPOGEN | 1.6 mL in 1 VIAL | INJECTION, SOLUTION | 1.6 | 164 | |
| 55513-546-10 | NEUPOGEN | 10 in 1 BOX | INJECTION, SOLUTION | 10 | 164 | |
| 55513-546-20 | NEUPOGEN | 10 in 1 BOX | INJECTION, SOLUTION | 10 | 164 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55513-546-01 | ML - Milliliter | 55513-546 | 432a83f4-9d08-4117-84ee-a524ffbbae2e | 1 | 2012-07-24 |
| 55513-546-10 | ML - Milliliter | 55513-546 | f0301283-9080-443b-bc23-e90f95a4c987 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FILGRASTIM, LICENSE HOLDER UNSPECIFIED | ACTIVE INGREDIENT | PVI5M0M1GW | NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC] | 144 | |
| FILGRASTIM, LICENSE HOLDER UNSPECIFIED | ACTIVE MOIETY | PVI5M0M1GW | NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC] | 144 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC] | 144 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC] | 144 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC] | 144 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC] | 144 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEUPOGEN (FILGRASTIM) INJECTION, SOLUTION [AMGEN INC] | 144 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 727535 | filgrastim 300 MCG in 0.5 ML Prefilled Syringe | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649944 | filgrastim 300 MCG in 1 ML Injection | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727544 | filgrastim 480 MCG in 0.8 ML Prefilled Syringe | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649963 | filgrastim 480 MCG in 1.6 ML Injection | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727537 | Neupogen 300 MCG in 0.5 ML Prefilled Syringe | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649946 | Neupogen 300 MCG in 1 ML Injection | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727545 | Neupogen 480 MCG in 0.8 ML Prefilled Syringe | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649964 | Neupogen 480 MCG in 1.6 ML Injection | PSN | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727537 | 0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen] | SBD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727545 | 0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe [Neupogen] | SBD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649946 | 1 ML filgrastim 0.3 MG/ML Injection [Neupogen] | SBD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649964 | 1.6 ML filgrastim 0.3 MG/ML Injection [Neupogen] | SBD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727535 | 0.5 ML filgrastim 0.6 MG/ML Prefilled Syringe | SCD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727544 | 0.8 ML filgrastim 0.6 MG/ML Prefilled Syringe | SCD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649944 | 1 ML filgrastim 0.3 MG/ML Injection | SCD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649963 | 1.6 ML filgrastim 0.3 MG/ML Injection | SCD | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727537 | 0.5 ML Neupogen 0.6 MG/ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727545 | 0.8 ML Neupogen 0.6 MG/ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649946 | 1 ML Neupogen 0.3 MG/ML Injection | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649964 | 1.6 ML Neupogen 0.3 MG/ML Injection | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727535 | filgrastim 0.3 MG per 0.5 ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727544 | filgrastim 0.48 MG per 0.8 ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727535 | filgrastim 300 MCG per 0.5 ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649944 | filgrastim 300 MCG per 1 ML Injection | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727544 | filgrastim 480 MCG per 0.8 ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649963 | filgrastim 480 MCG per 1.6 ML Injection | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727537 | Neupogen 300 MCG per 0.5 ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649946 | Neupogen 300 MCG per 1 ML Injection | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 727545 | Neupogen 480 MCG per 0.8 ML Prefilled Syringe | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
| 1649964 | Neupogen 480 MCG per 1.6 ML Injection | SY | 97cc73cc-b5b7-458a-a933-77b00523e193 | 164 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55513-546-01 | 55513054601 | 1.6 mL in 1 VIAL | 1.6 ml | Historical | ||||
| 55513-546-10 | 55513054610 | 10 VIAL in 1 BOX (55513-546-10) / 1.6 mL in 1 VIAL (55513-546-01) | 10 vial | 1997-04-07 | 0000-00-00 | No | No | Current |
| 55513-546-20 | 55513054620 | 10 VIAL in 1 BOX (55513-546-20) / 1.6 mL in 1 VIAL (55513-546-01) | 10 vial | 2025-10-01 | No | No | Historical |