Diprivan
- Product NDC
- 63323-269
- Requested package NDC
- 63323-269-67
- 11-digit product format
- 633230269
- Labeler code
- 63323
- Product ID
- 63323-269_45b28fb6-e455-43b8-b54e-e5d70ad3da22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROPOFOL
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA019627
- Marketing category
- NDA
- Marketing start
- 2009-11-17
- Substance
- PROPOFOL
- Active strength
- 10 mg/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019627-001 | DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | ||
| N019627-002 | DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019627-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N019627-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | e3105799-a4b6-f3f4-e6e2-b2b29bbdb538 | 2025-09-11 | Warnings, Adverse reactions | 019627 NDA019627 63323-269-67 63323-269 63323026967 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | fee3bd4a-ade3-41fa-839a-48e9af69bcf4 | 2025-09-10 | Warnings, Adverse reactions | 019627 NDA019627 63323-269 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | d1ae9e26-ffd6-43df-bbd6-869cdede6afe | 2025-04-21 | Warnings, Adverse reactions | 019627 NDA019627 63323-269 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | ee0c3437-614d-4631-a061-257f5f60c70b | 2025-02-20 | Warnings, Adverse reactions | 019627 NDA019627 63323-269 |
| Diprivan | PROPOFOL | Fresenius Kabi USA, LLC | 5cec3b97-5183-4a9d-accd-21e76c99d3dd | 2024-04-18 | Warnings, Adverse reactions | 019627 NDA019627 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diprivan
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROPOFOL | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| YI7VU623SF | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1808217 | Internal RxNorm lookup |
| 1808219 | Internal RxNorm lookup |
| 1808222 | Internal RxNorm lookup |
| 1808223 | Internal RxNorm lookup |
| 1808224 | Internal RxNorm lookup |
| 1808225 | Internal RxNorm lookup |
| 1808234 | Internal RxNorm lookup |
| 1808235 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e3105799-a4b6-f3f4-e6e2-b2b29bbdb538 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b5dd1a36-1efc-430d-94c2-9f49a850da5f | Product name | 6 | 20250317 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-269-01 | Diprivan | 10 mL in 1 VIAL | INJECTION, EMULSION | 10 | 14 | |
| 63323-269-10 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 14 | |
| 63323-269-22 | Diprivan | 20 mL in 1 VIAL | INJECTION, EMULSION | 20 | 14 | |
| 63323-269-29 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 14 | |
| 63323-269-30 | Diprivan | 50 mL in 1 VIAL | INJECTION, EMULSION | 50 | 14 | |
| 63323-269-35 | Diprivan | 100 mL in 1 VIAL | INJECTION, EMULSION | 100 | 14 | |
| 63323-269-50 | Diprivan | 20 in 1 BOX | INJECTION, EMULSION | 20 | 14 | |
| 63323-269-65 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 14 | |
| 63323-269-06 | Diprivan | 10 mL in 1 VIAL | INJECTION, EMULSION | 10 | 10 | |
| 63323-269-16 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 10 | |
| 63323-269-21 | Diprivan | 100 mL in 1 VIAL | INJECTION, EMULSION | 100 | 10 | |
| 63323-269-23 | Diprivan | 50 mL in 1 VIAL | INJECTION, EMULSION | 50 | 10 | |
| 63323-269-25 | Diprivan | 20 mL in 1 VIAL | INJECTION, EMULSION | 20 | 10 | |
| 63323-269-37 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 10 | |
| 63323-269-57 | Diprivan | 20 in 1 BOX | INJECTION, EMULSION | 20 | 10 | |
| 63323-269-67 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 10 | |
| 63323-269-41 | Diprivan | 100 mL in 1 VIAL | INJECTION, EMULSION | 100 | 9 | |
| 63323-269-43 | Diprivan | 20 mL in 1 VIAL | INJECTION, EMULSION | 20 | 9 | |
| 63323-269-45 | Diprivan | 50 mL in 1 VIAL | INJECTION, EMULSION | 50 | 9 | |
| 63323-269-59 | Diprivan | 20 in 1 BOX | INJECTION, EMULSION | 20 | 9 | |
| 63323-269-69 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 9 | |
| 63323-269-94 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 9 | |
| 63323-269-31 | Diprivan | 100 mL in 1 VIAL | INJECTION, EMULSION | 100 | 6 | |
| 63323-269-33 | Diprivan | 20 mL in 1 VIAL | INJECTION, EMULSION | 20 | 6 | |
| 63323-269-70 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 6 | |
| 63323-269-75 | Diprivan | 50 mL in 1 VIAL | INJECTION, EMULSION | 50 | 6 | |
| 63323-269-77 | Diprivan | 20 in 1 BOX | INJECTION, EMULSION | 20 | 6 | |
| 63323-269-78 | Diprivan | 10 in 1 BOX | INJECTION, EMULSION | 10 | 6 |
DailyMed Billing Units#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-269 | DIPRIVAN (PROPOFOL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC] | 14 | Current NDC, Legacy NDC, 8 package rows | 20250316_ee0c3437-614d-4631-a061-257f5f60c70b.zip |
| 63323-269 | DIPRIVAN (PROPOFOL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC] | 9 | Current NDC, Legacy NDC, 8 package rows | 20231129_e3105799-a4b6-f3f4-e6e2-b2b29bbdb538.zip |
| 63323-269 | DIPRIVAN (PROPOFOL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC] | 9 | Current NDC, Legacy NDC, 6 package rows | 20250515_d1ae9e26-ffd6-43df-bbd6-869cdede6afe.zip |
| 63323-269 | DIPRIVAN (PROPOFOL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 6 package rows | 20231201_fee3bd4a-ade3-41fa-839a-48e9af69bcf4.zip |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-269-67 | 63323026967 | 10 VIAL in 1 BOX (63323-269-67) / 100 mL in 1 VIAL (63323-269-21) | 10 vial | 2009-11-17 | 0000-00-00 | No | No | Current |