PROPOFOL

Product NDC
51662-1293
11-digit product format
516621293
Labeler code
51662
Product ID
51662-1293_ef6c0627-685d-7864-e053-2a95a90a2919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPOFOL
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA077908
Marketing category
ANDA
Marketing start
2018-11-26
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077908-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077908-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-173f01610625f2…
2019-09-15 20:21 UTC2019-09A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077908-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077908-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077908-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077908-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077908-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077908-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077908-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077908-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077908-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077908-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077908-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077908-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077908-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077908-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077908-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077908-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077908-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077908-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077908-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077908-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077908-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077908-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077908-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077908-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077908-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077908-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077908-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077908-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077908-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077908-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077908-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077908-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077908-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077908-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077908-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077908-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077908-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077908-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077908-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077908-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
PROPOFOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPOFOL10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YI7VU623SFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1808224Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b9599e0-5bad-742d-e053-2991aa0aee97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dd1a36-1efc-430d-94c2-9f49a850da5fProduct name620250317
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1293-1PROPOFOL20 mL in 1 VIALINJECTION, EMULSION204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1293PROPOFOL INJECTION, EMULSION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 1 package rows20221211_7b9599e0-5bad-742d-e053-2991aa0aee97.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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPOFOLPROPOFOLHospira, Inc.28d7ba00-f824-4e55-139a-03f509c099db2026-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077908
application number: ANDA077908
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst99af9e0a-c268-84ca-e053-2a95a90a0a3e2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077908
application number: ANDA077908
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst99c8438a-2b3c-796e-e053-2a95a90a02002025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077908
application number: ANDA077908
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst7b9599e0-5bad-742d-e053-2991aa0aee972022-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077908
application number: ANDA077908
ndc (product): 51662-1293

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808224propofol 200 MG in 20 ML InjectionPSN7b9599e0-5bad-742d-e053-2991aa0aee974
180822420 ML propofol 10 MG/ML InjectionSCD7b9599e0-5bad-742d-e053-2991aa0aee974
1808224propofol 200 MG per 20 ML InjectionSY7b9599e0-5bad-742d-e053-2991aa0aee974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1293-15166212930120 mL in 1 VIAL (51662-1293-1) 20 ml2018-11-260000-00-00NoNoCurrent