Hydrocortisone Rectal Suspension (Retention)

Product NDC: 62135-020
11-digit product format: 621350020
Labeler code: 62135
Product ID: 62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: SUSPENSION
Route: RECTAL
Labeler: Chartwell RX LLC
Application: ANDA075172
Marketing category: ANDA
Marketing start: 1999-12-03
Substance: HYDROCORTISONE
Active strength: 100 mg/60mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 42.

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
A075172-001	COLOCORT	HYDROCORTISONE	100MG/60ML	ENEMA / RECTAL	AB		1999-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075172-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075172-001	COLOCORT	100MG/60ML	ENEMA / RECTAL	AB	1999-12-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075172-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075172-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075172-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075172-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075172-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075172-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075172-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075172-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075172-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075172-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075172-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075172-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075172-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075172-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075172-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075172-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075172-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075172-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075172-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075172-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075172-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075172-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075172-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075172-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075172-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075172-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075172-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075172-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075172-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075172-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075172-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075172-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075172-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075172-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075172-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075172-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075172-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075172-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075172-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075172-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocortisone Rectal Suspension (Retention)
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8	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
62135-020-07	Hydrocortisone Rectal Suspension (Retention)	60 mL in 1 BOTTLE	SUSPENSION	60	6
62135-020-07	Hydrocortisone Rectal Suspension (Retention)	7 in 1 CARTON	SUSPENSION	7	6
62135-020-21	Hydrocortisone Rectal Suspension (Retention)	3 in 1 BOX	SUSPENSION	3	6
62135-020-21	Hydrocortisone Rectal Suspension (Retention)	7 in 1 CARTON	SUSPENSION	7	6
62135-020-46	Hydrocortisone Rectal Suspension (Retention)	60 mL in 1 BOTTLE	SUSPENSION	60	6
62135-020-46	Hydrocortisone Rectal Suspension (Retention)	1 in 1 CARTON	SUSPENSION	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-020-07	ML - Milliliter	62135-020	477276bb-3342-4028-aeb8-8548e55d3bad	1	2021-10-08
62135-020-21	ML - Milliliter	62135-020	af82ca3e-4f22-4d62-b456-a6576045cc26	1	2021-12-08
62135-020-46	ML - Milliliter	62135-020	5b81a40a-b0c3-4143-b3d3-8c308359abc3	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-020	HYDROCORTISONE RECTAL SUSPENSION (RETENTION) (HYDROCORTISONE) SUSPENSION [CHARTWELL RX LLC]	5	Current NDC, Legacy NDC, 6 package rows	20241030_3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8.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
Hydrocortisone Rectal Suspension (Retention)	HYDROCORTISONE	Chartwell RX LLC	3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075172 application number: ANDA075172 ndc (product): 62135-020
Hydrocortisone	HYDROCORTISONE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc	ded2eb00-88ce-42b7-858e-4645c6f13239	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075172 application number: ANDA075172

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
310878	hydrocortisone 100 MG in 60 mL Rectal Enema	PSN	3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8	6
310878	hydrocortisone 1.67 MG/ML Enema	SCD	3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8	6
310878	hydrocortisone 100 MG per 60 ML Rectal Enema	SY	3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62135-020-07	62135002007	7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE	7 bottle	2021-09-06	0000-00-00	No	No	Current
62135-020-21	62135002021	3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE	3 carton	2021-11-18	0000-00-00	No	No	Current
62135-020-46	62135002046	1 BOTTLE in 1 CARTON (62135-020-46) / 60 mL in 1 BOTTLE	1 bottle	2021-09-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Rectal Suspension (Retention)	Chartwell RX LLC	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	6