SYMJEPI

Product NDC: 38739-200
11-digit product format: 387390200
Labeler code: 38739
Product ID: 38739-200_aea6fa4f-6916-4e6c-96f8-d2c47b332314
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Epinephrine
Dosage form: INJECTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: Adamis Pharmaceuticals Corporation
Application: NDA207534
Marketing category: NDA
Marketing start: 2017-11-15
Marketing end: 0000-00-00
Substance: EPINEPHRINE
Active strength: 0 mg/.3mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	38739-200		I	Inactivated by FDA	2026-08-10
excluded package	package	38739-200	38739-200-06	I	Inactivated by FDA	2026-08-10
excluded package	package	38739-200	38739-200-12	I	Inactivated by FDA	2026-08-10

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 · 57 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	38739-200-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	38739-200-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	38739-200-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	38739-200-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	38739-200-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	38739-200-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	38739-200-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	38739-200-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	38739-200-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	38739-200-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	38739-200-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	38739-200-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	38739-200-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	38739-200-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	38739-200-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	38739-200-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	38739-200-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	38739-200-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	38739-200-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	38739-200-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	38739-200-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	38739-200-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	38739-200-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	38739-200-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	38739-200-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	38739-200-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	38739-200-06	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	38739-200-12	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	38739-200-06	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	38739-200-12	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	38739-200-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	38739-200-12	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	38739-200-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	38739-200-12	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	38739-200-06	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	38739-200-12	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	38739-200-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	38739-200-12	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207534-001	SYMJEPI	EPINEPHRINE	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD, RS	2017-06-15
N207534-002	SYMJEPI	EPINEPHRINE	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2018-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16
N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`a67488948f0b…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
38739-200-06	2021-01-29	C162847	48780-1	ba0f9c33-0fe5-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use SYMJEPI™ safely and effectively. See full prescribing information for SYMJEPI™. SYMJEPI™ (epinephrine) injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939
38739-200-12	2021-01-29	C162847	48780-1	ba0f9c33-0fe5-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use SYMJEPI™ safely and effectively. See full prescribing information for SYMJEPI™. SYMJEPI™ (epinephrine) injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
38739-200-01	SYMJEPI	0.3 mL in 1 SYRINGE	INJECTION	0.3	3
38739-200-01	SYMJEPI	1 in 1 CARTON	INJECTION	1	3
38739-200-02	SYMJEPI	0.3 mL in 1 SYRINGE	INJECTION	0.3	3
38739-200-02	SYMJEPI	2 in 1 CARTON	INJECTION	2	3
38739-200-06	SYMJEPI	6 in 1 CARTON	INJECTION	6	3
38739-200-12	SYMJEPI	6 in 1 CARTON	INJECTION	6	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
38739-200	SYMJEPI (EPINEPHRINE) INJECTION [ADAMIS PHARMACEUTICALS CORPORATION]	3	Legacy NDC, 6 package rows	20190207_4b414a33-7371-4801-ae16-59db8c7b1aab.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YKH834O4BH	EPINEPHRINE	51-43-4	EPINEPHRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1989112	EPINEPHrine 0.3 MG in 0.3 ML Prefilled Syringe	PSN	4b414a33-7371-4801-ae16-59db8c7b1aab	3
1989117	SYMJEPI 0.3 MG in 0.3 mL Prefilled Syringe	PSN	4b414a33-7371-4801-ae16-59db8c7b1aab	3
1989117	0.3 ML epinephrine 1 MG/ML Prefilled Syringe [Symjepi]	SBD	4b414a33-7371-4801-ae16-59db8c7b1aab	3
1989112	0.3 ML epinephrine 1 MG/ML Prefilled Syringe	SCD	4b414a33-7371-4801-ae16-59db8c7b1aab	3
1989117	0.3 ML Symjepi 1 MG/ML Prefilled Syringe	SY	4b414a33-7371-4801-ae16-59db8c7b1aab	3
1989112	epinephrine 0.3 MG per 0.3 ML Prefilled Syringe	SY	4b414a33-7371-4801-ae16-59db8c7b1aab	3
1989117	Symjepi 0.3 MG per 0.3 ML Prefilled Syringe	SY	4b414a33-7371-4801-ae16-59db8c7b1aab	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
38739-200-01	38739020001	0.3 mL in 1 SYRINGE	0.3 ml	Historical
38739-200-02	38739020002	0.3 mL in 1 SYRINGE	0.3 ml	Historical
38739-200-06	38739020006	6 in 1 CARTON		Historical
38739-200-12	38739020012	6 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SYMJEPI	Adamis Pharmaceuticals Corporation \| Catalent Belgium S.A.	2019-02-06	HUMAN PRESCRIPTION DRUG LABEL	3