Diprivan
- Product NDC
- 63323-269
- Requested package NDC
- 63323-269-37
- 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N019627-001 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | 1989-10-02 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019627-002 | DIPRIVAN | 10MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1996-06-11 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019627-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019627-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019627-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019627-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019627-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019627-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019627-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019627-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019627-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019627-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019627-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019627-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019627-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019627-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019627-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019627-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019627-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019627-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019627-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N019627-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019627-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N019627-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N019627-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N019627-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N019627-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019627-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019627-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019627-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N019627-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N019627-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019627-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019627-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019627-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019627-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N019627-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N019627-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019627-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N019627-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N019627-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019627-002 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019627-002 | 8476010*PED | 2025-06-01 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019627-002 | 8476010 | 2024-12-01 | Drug substance, Drug product | 2013-07-02 | 8869cabd3fbd… |
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 63323-269-37 63323-269 63323026937 |
| 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 |
|---|---|---|---|---|---|---|---|---|
| 63323-269-37 | 63323026937 | 10 VIAL in 1 BOX (63323-269-37) / 20 mL in 1 VIAL (63323-269-25) | 10 vial | 2009-11-17 | 0000-00-00 | No | No | Current |