Epinephrine

Product NDC: 76420-188
Requested package NDC: 76420-188-02
11-digit product format: 764200188
Labeler code: 76420
Product ID: 76420-188_ead5985f-7585-52ae-e053-2a95a90affce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Epinephrine
Dosage form: INJECTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: Asclemed USA, Inc.
Application: ANDA090589
Marketing category: ANDA
Marketing start: 2018-11-27
Substance: EPINEPHRINE
Active strength: .3 mg/.3mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [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 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
A090589-001	EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB		2018-08-16
A090589-002	EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB		2018-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090589-001	AB
A090589-002	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.

Product history page 1 of 3 · 82 observed 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
2026-02-19 14:30 UTC	2026-02	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090589-001	EPINEPHRINE (AUTOINJECTOR)	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090589-002	EPINEPHRINE (AUTOINJECTOR)	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	2018-08-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090589-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090589-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090589-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090589-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090589-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090589-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090589-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090589-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090589-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090589-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090589-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090589-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090589-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090589-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090589-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090589-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090589-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090589-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090589-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090589-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090589-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090589-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090589-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090589-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090589-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090589-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090589-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090589-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090589-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090589-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090589-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090589-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090589-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090589-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090589-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090589-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090589-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090589-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090589-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090589-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPINEPHRINE	.3 mg/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YKH834O4BH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1870207	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
099bc72c-8ffe-4b8c-9608-044c864982fb	Available on FDA.report

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-188-02	Epinephrine	0.3 mL in 1 SYRINGE	INJECTION	0.3		2
76420-188-02	Epinephrine	2 in 1 PACKAGE	INJECTION	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-188	EPINEPHRINE INJECTION [ASCLEMED USA, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20221013_099bc72c-8ffe-4b8c-9608-044c864982fb.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epinephrine	EPINEPHRINE	Sportpharm LLC	3a8f5ca2-6c1d-4011-9266-ba93c7a3abb9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090589 application number: ANDA090589
Epinephrine	EPINEPHRINE	REMEDYREPACK INC.	de4916c5-bdc8-4da9-a857-a319882a831a	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090589 application number: ANDA090589
Epinephrine	EPINEPHRINE	A-S Medication Solutions	ab5e23d0-6e99-4647-838d-23a4040602b5	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090589 application number: ANDA090589
Epinephrine	EPINEPHRINE	Redpharm Drug	300ac735-4493-c02a-e063-6294a90a5bce	2025-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090589 application number: ANDA090589
Epinephrine	EPINEPHRINE	Bryant Ranch Prepack	a7ae17f8-de81-4de9-a89f-bb930c6a27ec	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090589 application number: ANDA090589
Epinephrine	EPINEPHRINE	Asclemed USA, Inc.	099bc72c-8ffe-4b8c-9608-044c864982fb	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090589 application number: ANDA090589 ndc (package): 76420-188-02 ndc (product): 76420-188 ndc11 (package): 76420018802
Epinephrine	EPINEPHRINE	Teva Pharmaceuticals USA, Inc.	04f07f15-55e2-411b-abb8-07eab37f5664	2021-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090589 application number: ANDA090589

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
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	099bc72c-8ffe-4b8c-9608-044c864982fb	2
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	099bc72c-8ffe-4b8c-9608-044c864982fb	2
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	099bc72c-8ffe-4b8c-9608-044c864982fb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-188-02	76420018802	2 SYRINGE in 1 PACKAGE (76420-188-02) / .3 mL in 1 SYRINGE	2 syringe	2021-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Epinephrine	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2