Cortenema

Product NDC: 62559-111
11-digit product format: 625590111
Labeler code: 62559
Product ID: 62559-111_45040499-9056-45bd-9e0f-113b619fc6ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: ENEMA
Route: RECTAL
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA016199
Marketing category: NDA
Marketing start: 2012-08-10
Substance: HYDROCORTISONE
Active strength: 100 mg/60mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
N016199-001	CORTENEMA	HYDROCORTISONE	100MG/60ML	ENEMA / RECTAL	AB	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
N016199-001	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.

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	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016199-001	CORTENEMA	100MG/60ML	ENEMA / RECTAL	AB	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	N016199-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016199-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016199-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016199-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016199-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016199-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016199-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016199-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016199-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016199-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016199-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016199-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016199-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016199-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016199-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016199-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016199-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016199-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016199-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016199-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016199-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016199-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016199-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016199-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016199-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016199-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016199-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016199-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016199-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016199-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016199-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016199-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016199-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016199-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016199-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016199-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016199-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016199-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016199-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016199-001	AB	1	`f41ea6bd6efb…`

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: Cortenema
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	100 mg/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
102250	Internal RxNorm lookup
310878	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
a307448a-ccc4-41a8-977a-11f28f0bded9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62559-111-07	Cortenema	60 mL in 1 BOTTLE, UNIT-DOSE	ENEMA	60	5
62559-111-07	Cortenema	7 in 1 CARTON	ENEMA	7	5
62559-111-11	Cortenema	1 in 1 CARTON	ENEMA	1	5
62559-111-11	Cortenema	60 mL in 1 BOTTLE, UNIT-DOSE	ENEMA	60	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-111-07	ML - Milliliter	62559-111	89a64d26-46dc-47a3-980a-9545d60d9f15	1	2013-05-02
62559-111-11	ML - Milliliter	62559-111	6f102c1c-f9dd-451a-9d27-cfd0b64840a5	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	CORTENEMA (HYDROCORTISONE) ENEMA [ANIP ACQUISITION COMPANY]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	CORTENEMA (HYDROCORTISONE) ENEMA [ANIP ACQUISITION COMPANY]	1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	CORTENEMA (HYDROCORTISONE) ENEMA [ANIP ACQUISITION COMPANY]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CORTENEMA (HYDROCORTISONE) ENEMA [ANIP ACQUISITION COMPANY]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CORTENEMA (HYDROCORTISONE) ENEMA [ANIP ACQUISITION COMPANY]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CORTENEMA (HYDROCORTISONE) ENEMA [ANIP ACQUISITION COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CORTENEMA (HYDROCORTISONE) ENEMA [ANIP ACQUISITION COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-111	CORTENEMA (HYDROCORTISONE) ENEMA [ANI PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 4 package rows	20220427_a307448a-ccc4-41a8-977a-11f28f0bded9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortenema	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	a307448a-ccc4-41a8-977a-11f28f0bded9	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016199 application number: NDA016199 ndc (product): 62559-111
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	40654d12-56e4-4489-be49-19c60ad918ad	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016199 application number: NDA016199

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
102250	Cortenema 100 MG in 60 mL Enema	PSN	a307448a-ccc4-41a8-977a-11f28f0bded9	5
310878	hydrocortisone 100 MG in 60 mL Rectal Enema	PSN	a307448a-ccc4-41a8-977a-11f28f0bded9	5
102250	hydrocortisone 1.67 MG/ML Enema [Cortenema]	SBD	a307448a-ccc4-41a8-977a-11f28f0bded9	5
310878	hydrocortisone 1.67 MG/ML Enema	SCD	a307448a-ccc4-41a8-977a-11f28f0bded9	5
102250	Cortenema 1.67 MG/ML Enema	SY	a307448a-ccc4-41a8-977a-11f28f0bded9	5
102250	Cortenema 100 MG per 60 ML Enema	SY	a307448a-ccc4-41a8-977a-11f28f0bded9	5
310878	hydrocortisone 100 MG per 60 ML Rectal Enema	SY	a307448a-ccc4-41a8-977a-11f28f0bded9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-111-07	62559011107	7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE	2012-08-10	0000-00-00	No	No	Current
62559-111-11	62559011111	1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE	2012-08-10	0000-00-00	No	No	Current