NOVOLOG
- Product NDC
- 0169-6339
- 11-digit product format
- 001696339
- Labeler code
- 0169
- Product ID
- 0169-6339_de82c22d-ea25-44ef-8bcd-c3cda9e84e59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin aspart
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Novo Nordisk
- Application
- BLA020986
- Marketing category
- BLA
- Marketing start
- 2003-01-22
- Substance
- INSULIN ASPART
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0169-6339 | 0169-6339-97 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NOVOLOG
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| INSULIN ASPART | 100 [iU]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| D933668QVX | Internal UNII lookup |
| 059QF0KO0R | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0169-6339-10 | NOVOLOG | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | 34 | |
| 0169-6339-10 | NOVOLOG | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 34 | |
| 0169-6339-90 | NOVOLOG | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | 34 | |
| 0169-6339-97 | NOVOLOG | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 34 | |
| 0169-6339-98 | NOVOLOG | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 34 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0169-6339-10 | ML - Milliliter | 0169-6339 | ad3dda81-4f5a-4c6b-8ce2-39f5d9aa2c43 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0169-6339 | NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION) INJECTION, SOLUTION [NOVO NORDISK] | 34 | Current NDC, Legacy NDC, 5 package rows | 20250122_3a1e73a2-3009-40d0-876c-b4cb2be56fc5.zip |
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 |
|---|---|---|---|---|---|---|
| Insulin Aspart | INSULIN ASPART | REMEDYREPACK INC. | b3d77cb0-cd47-441f-8f54-5329c655da9c | 2026-01-14 | Warnings, Adverse reactions | BLA020986 |
| Insulin Aspart | INSULIN ASPART | A-S Medication Solutions | c3e4c46e-5211-4f05-b7ab-1e9ad270876b | 2024-09-11 | Warnings, Adverse reactions | BLA020986 |
| Insulin Aspart | INSULIN ASPART | A-S Medication Solutions | bfd2b192-35e5-4773-ab73-802565b2ad78 | 2024-03-14 | Warnings, Adverse reactions | BLA020986 |
| NOVOLOG | INSULIN ASPART | A-S Medication Solutions | 13891e5a-e57a-46e8-911c-2f680352b52b | 2023-12-15 | Warnings, Adverse reactions | BLA020986 |
| NOVOLOG | INSULIN ASPART | A-S Medication Solutions | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 2023-12-09 | Warnings, Adverse reactions | BLA020986 |
| Insulin Aspart | INSULIN ASPART | Novo Nordisk Pharma, Inc. | bee5b358-c863-420b-be73-ced2e920c499 | 2023-02-28 | Warnings, Adverse reactions | BLA020986 |
| Insulin Diluting Medium for NovoLog | WATER INJECTION | Novo Nordisk | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 2023-02-28 | Warnings, Adverse reactions | BLA020986 0169-6339 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 020986 | Novolog | insulin aspart | 351(a) | Rx | 2026-07-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1653196 | insulin aspart 100 UNT/ML in 3 ML Cartridge | PSN | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653202 | insulin aspart 100 UNT/ML in 3 ML Pen Injector | PSN | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 311040 | insulin aspart 100 UNT/ML Injectable Solution | PSN | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653198 | NovoLOG 100 UNT/ML in 3 ML Cartridge | PSN | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653204 | NovoLOG 100 UNT/ML in 3 ML Pen Injector | PSN | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 351926 | NovoLOG 100 UNT/ML Injectable Solution | PSN | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653198 | 3 ML insulin aspart, human 100 UNT/ML Cartridge [NovoLog] | SBD | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653204 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog] | SBD | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 351926 | insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog] | SBD | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653196 | 3 ML insulin aspart, human 100 UNT/ML Cartridge | SCD | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653202 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector | SCD | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 311040 | insulin aspart, human 100 UNT/ML Injectable Solution | SCD | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653198 | 3 ML NovoLog 100 UNT/ML Cartridge | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653204 | 3 ML NovoLog 100 UNT/ML Pen Injector | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 311040 | insulin analog, aspart 100 UNT/ML Injectable Solution | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653196 | insulin, aspart, human 100 UNT/ML per 3 ML Cartridge | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653202 | insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 351926 | NovoLog 100 UNT/ML Injectable Solution | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653204 | NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653204 | NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector | SY | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 34 |
| 1653196 | insulin aspart 100 UNT/ML in 3 ML Cartridge | PSN | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653202 | insulin aspart 100 UNT/ML in 3 ML Pen Injector | PSN | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 311040 | insulin aspart 100 UNT/ML Injectable Solution | PSN | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653198 | NovoLOG 100 UNT/ML in 3 ML Cartridge | PSN | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653204 | NovoLOG 100 UNT/ML in 3 ML Pen Injector | PSN | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 351926 | NovoLOG 100 UNT/ML Injectable Solution | PSN | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653198 | 3 ML insulin aspart, human 100 UNT/ML Cartridge [NovoLog] | SBD | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653204 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog] | SBD | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 351926 | insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog] | SBD | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653196 | 3 ML insulin aspart, human 100 UNT/ML Cartridge | SCD | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653202 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector | SCD | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 311040 | insulin aspart, human 100 UNT/ML Injectable Solution | SCD | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653198 | 3 ML NovoLog 100 UNT/ML Cartridge | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653204 | 3 ML NovoLog 100 UNT/ML Pen Injector | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 311040 | insulin analog, aspart 100 UNT/ML Injectable Solution | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653196 | insulin, aspart, human 100 UNT/ML per 3 ML Cartridge | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653202 | insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 351926 | NovoLog 100 UNT/ML Injectable Solution | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653204 | NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653204 | NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector | SY | e172b4f8-9b25-4019-8e09-afc10b2f30c9 | 28 |
| 1653202 | insulin aspart 100 UNT/ML in 3 ML Pen Injector | PSN | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653204 | NovoLOG 100 UNT/ML in 3 ML Pen Injector | PSN | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653204 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog] | SBD | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653202 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector | SCD | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653204 | 3 ML NovoLog 100 UNT/ML Pen Injector | SY | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653202 | insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector | SY | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653204 | NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector | SY | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653204 | NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector | SY | 13891e5a-e57a-46e8-911c-2f680352b52b | 6 |
| 1653202 | insulin aspart 100 UNT/ML in 3 ML Pen Injector | PSN | cd88e313-6193-4413-beff-7d955580060d | 1 |
| 1653204 | NovoLOG 100 UNT/ML in 3 ML Pen Injector | PSN | cd88e313-6193-4413-beff-7d955580060d | 1 |
| 1653204 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog] | SBD | cd88e313-6193-4413-beff-7d955580060d | 1 |
| 1653202 | 3 ML insulin aspart, human 100 UNT/ML Pen Injector | SCD | cd88e313-6193-4413-beff-7d955580060d | 1 |
| 1653204 | 3 ML NovoLog 100 UNT/ML Pen Injector | SY | cd88e313-6193-4413-beff-7d955580060d | 1 |
| 1653202 | insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector | SY | cd88e313-6193-4413-beff-7d955580060d | 1 |
| 1653204 | NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector | SY | cd88e313-6193-4413-beff-7d955580060d | 1 |
| 1653204 | NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector | SY | cd88e313-6193-4413-beff-7d955580060d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0169-6339-10 | 00169633910 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-6339-10) / 3 mL in 1 SYRINGE, PLASTIC | 2003-01-22 | 0000-00-00 | No | No | Current | |
| 0169-6339-90 | 00169633990 | 3 mL in 1 SYRINGE, PLASTIC | 3 ml | Historical | ||||
| 0169-6339-97 | 00169633997 | 1 in 1 CARTON | Historical | |||||
| 0169-6339-98 | 00169633998 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-6339-98) / 3 mL in 1 SYRINGE, PLASTIC (0169-6339-90) | 2003-01-22 | 0000-00-00 | Yes | No | Current |