Analpram HC

Product NDC: 83107-019
11-digit product format: 831070019
Labeler code: 83107
Product ID: 83107-019_4dcbb97c-b493-022f-e063-6294a90ac089
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone acetate and pramoxine hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Legacy Pharma USA Inc.
Application: ANDA085979
Marketing category: ANDA
Marketing start: 2025-07-25
Substance: HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength: 25; 10 mg/g; mg/g
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 1.

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
A085979-001	PRAMOSONE	HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE	2.5%;1%	LOTION / TOPICAL		Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085979-001	PRAMOSONE	2.5%;1%	LOTION / TOPICAL	Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Analpram HC
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	25 mg/g
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1294025	Internal RxNorm lookup
1362211	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
3e5c6728-ece3-40f7-9e36-cff71f168cd8	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
83107-019-01	Analpram HC	28 g in 1 TUBE, WITH APPLICATOR	CREAM	28	2
83107-019-12	Analpram HC	12 in 1 CARTON	CREAM	12	2
83107-019-12	Analpram HC	4 g in 1 TUBE, WITH APPLICATOR	CREAM	4	2
83107-019-30	Analpram HC	30 in 1 CARTON	CREAM	30	2
83107-019-30	Analpram HC	4 g in 1 TUBE, WITH APPLICATOR	CREAM	4	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83107-019-01	GM - Gram	83107-019	d56a377c-f08e-44d5-bea4-2527aa106bce	1	2025-10-14
83107-019-12	GM - Gram	83107-019	05f54610-7ff3-4523-809b-0b988ffd5b3e	1	2026-02-05

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Analpram HC	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Legacy Pharma USA Inc.	3e5c6728-ece3-40f7-9e36-cff71f168cd8	2026-03-24	Adverse reactions	Exact identifier application applno (ANDA): 085979 application number: ANDA085979 ndc (product): 83107-019
Analpram HC	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Sebela Pharmaceuticals Inc.	1469733e-1723-4b8c-be33-ed8dfafd65e2	2025-11-08	Adverse reactions	Exact identifier application applno (ANDA): 085979 application number: ANDA085979
Pramosone	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Sebela Pharmaceuticals Inc.	63606801-4fa8-11e4-916c-0800200c9a66	2025-11-08	Adverse reactions	Exact identifier application applno (ANDA): 085979 application number: ANDA085979
Analpram HC	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Legacy Pharma USA Inc.	56568e1f-974b-4750-b560-d93eb5e0e83f	2025-06-09	Adverse reactions	Exact identifier application applno (ANDA): 085979 application number: ANDA085979
Pramosone	HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	Legacy Pharma USA Inc.	4c98a01e-ff11-45eb-8732-4bd9157969e8	2025-06-09	Adverse reactions	Exact identifier application applno (ANDA): 085979 application number: ANDA085979

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1362211	Analpram 2.5 % / 1 % Rectal Cream	PSN	3e5c6728-ece3-40f7-9e36-cff71f168cd8	2
1294025	hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal Cream	PSN	3e5c6728-ece3-40f7-9e36-cff71f168cd8	2
1362211	hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]	SBD	3e5c6728-ece3-40f7-9e36-cff71f168cd8	2
1294025	hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream	SCD	3e5c6728-ece3-40f7-9e36-cff71f168cd8	2
1362211	Analpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal Cream	SY	3e5c6728-ece3-40f7-9e36-cff71f168cd8	2
1294025	hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal Cream	SY	3e5c6728-ece3-40f7-9e36-cff71f168cd8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83107-019-01	83107001901	28 g in 1 TUBE, WITH APPLICATOR	28 g				Historical
83107-019-12	83107001912	12 TUBE, WITH APPLICATOR in 1 CARTON (83107-019-12) / 4 g in 1 TUBE, WITH APPLICATOR		2025-07-25	No	No	Current
83107-019-30	83107001930	30 TUBE, WITH APPLICATOR in 1 CARTON (83107-019-30) / 4 g in 1 TUBE, WITH APPLICATOR		2025-07-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Analpram HC ® hydrocortisone acetate 2.5% pramoxine HCl 1% Cream 2.5%	Legacy Pharma USA Inc.	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	2