FENTANYL CITRATE

Product NDC: 17478-030
Requested package NDC: 17478-030-10
11-digit product format: 174780030
Labeler code: 17478
Product ID: 17478-030_234d5a6d-8cc7-4c4e-87f4-4e3e2c5c90aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENTANYL CITRATE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Akorn
Application: NDA016619
Marketing category: NDA
Marketing start: 2012-03-22
Marketing end: 0000-00-00
Substance: FENTANYL CITRATE
Active strength: 50 ug/mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17478-030	17478-030-10	D	Discontinued by firm		2026-10-05

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.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
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…`

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
N016619-001	SUBLIMAZE PRESERVATIVE FREE	FENTANYL CITRATE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016619-001	AP

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016619-001	SUBLIMAZE PRESERVATIVE FREE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N016619-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016619-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016619-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016619-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016619-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016619-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016619-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016619-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016619-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016619-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016619-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016619-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016619-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016619-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016619-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016619-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016619-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016619-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016619-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016619-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016619-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016619-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016619-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016619-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016619-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016619-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016619-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016619-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016619-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016619-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016619-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016619-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016619-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016619-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016619-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016619-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016619-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016619-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016619-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016619-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3	Product name	1	20231002
a8df478d-5b88-9654-981b-87dff14dda8b	Product name	2	20190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57	Product name	2	20180118
bb365072-425e-ca0a-021e-fd8b78162502	Product name	2	20161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6	Product name	2	20160104
739fa0ac-b690-63c4-9904-e20dffbf78f9	Product name	1	20140508
7763fcbb-367d-ed06-b37f-e1529b6241be	Product name	1	20140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
17478-030-02	These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968
17478-030-05	These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968
17478-030-10	These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968
17478-030-20	These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968
17478-030-25	These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968
17478-030-55	These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-030-02	FENTANYL CITRATE	10 in 1 CARTON	INJECTION, SOLUTION	10	15
17478-030-02	FENTANYL CITRATE	2 mL in 1 AMPULE	INJECTION, SOLUTION	2	15
17478-030-05	FENTANYL CITRATE	5 mL in 1 AMPULE	INJECTION, SOLUTION	5	15
17478-030-05	FENTANYL CITRATE	10 in 1 CARTON	INJECTION, SOLUTION	10	15
17478-030-10	FENTANYL CITRATE	10 mL in 1 AMPULE	INJECTION, SOLUTION	10	15
17478-030-10	FENTANYL CITRATE	5 in 1 CARTON	INJECTION, SOLUTION	5	15
17478-030-20	FENTANYL CITRATE	20 mL in 1 AMPULE	INJECTION, SOLUTION	20	15
17478-030-20	FENTANYL CITRATE	5 in 1 CARTON	INJECTION, SOLUTION	5	15
17478-030-25	FENTANYL CITRATE	2 mL in 1 AMPULE	INJECTION, SOLUTION	2	15
17478-030-25	FENTANYL CITRATE	25 in 1 CARTON	INJECTION, SOLUTION	25	15
17478-030-55	FENTANYL CITRATE	25 in 1 CARTON	INJECTION, SOLUTION	25	15
17478-030-55	FENTANYL CITRATE	5 mL in 1 AMPULE	INJECTION, SOLUTION	5	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-030-02	ML - Milliliter	17478-030	f253556c-284c-4420-8292-3d2ee50e9f84	1	2012-07-24
17478-030-05	ML - Milliliter	17478-030	e2e53738-97b8-450f-89b4-e078ff1e6358	1	2012-07-24
17478-030-20	ML - Milliliter	17478-030	1dacc43f-507e-4989-a4e4-952979ca1695	1	2012-07-24
17478-030-25	ML - Milliliter	17478-030	e0247441-e1eb-4c4d-9075-dc95c6e1d032	1	2012-07-24
17478-030-55	ML - Milliliter	17478-030	27c4ceed-6d2c-4d59-98ac-e691352b756f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL CITRATE	ACTIVE INGREDIENT	MUN5LYG46H	FENTANYL CITRATE INJECTION [AKORN, INC.]	3
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL CITRATE INJECTION [AKORN, INC.]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	FENTANYL CITRATE INJECTION [AKORN, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-030	FENTANYL CITRATE INJECTION, SOLUTION [AKORN]	15	Legacy NDC, 12 package rows	20220914_c5d40297-b769-48cc-9f84-f98b7a333507.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MUN5LYG46H	FENTANYL CITRATE	990-73-8	FENTANYL CITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-030-10	17478003010	5 AMPULE in 1 CARTON (17478-030-10) > 10 mL in 1 AMPULE	5 ampule	2012-03-22	0000-00-00	No	No	Current