propofol

Product NDC: 16714-977
Requested package NDC: 16714-977-20
11-digit product format: 167140977
Labeler code: 16714
Product ID: 16714-977_562acb1a-ccd2-4b98-b4fd-807f2c3ee038
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propofol
Dosage form: INJECTION, EMULSION
Route: INTRAVENOUS
Labeler: NorthStar Rx LLC
Application: ANDA206408
Marketing category: ANDA
Marketing start: 2022-07-01
Substance: PROPOFOL
Active strength: 10 mg/mL
Pharmacologic classes: General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206408-001	PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB		2021-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206408-001	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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206408-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2021-10-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206408-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206408-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206408-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206408-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206408-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206408-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206408-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206408-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206408-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206408-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206408-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206408-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206408-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206408-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206408-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206408-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206408-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206408-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206408-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206408-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206408-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206408-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206408-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206408-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206408-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206408-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206408-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206408-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206408-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206408-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206408-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206408-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206408-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206408-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206408-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: propofol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPOFOL	10 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-977-01	propofol	50 mL in 1 VIAL	INJECTION, EMULSION	50		5
16714-977-20	propofol	20 in 1 CARTON	INJECTION, EMULSION	20		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-977-01	ML - Milliliter	16714-977	96a9fdf0-9e3e-423e-9869-e4a21ead5918	1	2022-09-12
16714-977-20	ML - Milliliter	16714-977	1cf70723-d83c-4b2c-bc7b-9c767e776127	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-977	PROPOFOL INJECTION, EMULSION [NORTHSTAR RX LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241207_5ec25932-6c21-4cd5-8f60-80761f2e20a6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
propofol	PROPOFOL	NorthStar Rx LLC	5ec25932-6c21-4cd5-8f60-80761f2e20a6	2025-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206408 application number: ANDA206408 ndc (package): 16714-977-20 ndc (product): 16714-977 ndc11 (package): 16714097720
propofol	PROPOFOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	10272dc1-657d-4798-a34a-b6341b92e560	2025-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206408 application number: ANDA206408
Propofol	PROPOFOL	Avenacy, LLC	de351d5f-581d-4768-a4af-fbd8e5bce264	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206408 application number: ANDA206408

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YI7VU623SF	PROPOFOL	2078-54-8	PROPOFOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1808217	propofol 1000 MG in 100 ML Injection	PSN	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808224	propofol 200 MG in 20 ML Injection	PSN	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808222	propofol 500 MG in 50 ML Injection	PSN	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808217	100 ML propofol 10 MG/ML Injection	SCD	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808224	20 ML propofol 10 MG/ML Injection	SCD	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808222	50 ML propofol 10 MG/ML Injection	SCD	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808217	propofol 1000 MG per 100 ML Injection	SY	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808224	propofol 200 MG per 20 ML Injection	SY	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5
1808222	propofol 500 MG per 50 ML Injection	SY	5ec25932-6c21-4cd5-8f60-80761f2e20a6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-977-20	16714097720	20 VIAL in 1 CARTON (16714-977-20) / 50 mL in 1 VIAL (16714-977-01)	20 vial	2025-06-02	0000-00-00	No	No	Current