Home NDC 64980-302 Procto-Pak
Product NDC 64980-302
11-digit product format 649800302
Labeler code 64980
Product ID 64980-302_384f2adf-43c5-410b-8a1e-d856ac3d8a17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Rising Pharmaceuticals, Inc.
Application ANDA087795
Marketing category ANDA
Marketing start 2012-06-01
Marketing end 0000-00-00
Substance HYDROCORTISONE
Active strength 10 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64980-302-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64980-302-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64980-302-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64980-302-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64980-302-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64980-302-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64980-302-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64980-302-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64980-302-30 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64980-302-30 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64980-302-30 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64980-302-30 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64980-302-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 64980-302-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 64980-302-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 64980-302-30 I Inactivated by FDA bd6a592717d7…303034d00443…
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 A087795-001 HYDROCORTISONE HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087795-001 AT
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087795-001 HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 PARAFFIN INACTIVE INGREDIENT I9O0E3H2ZE PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-302-30 64980030230 1 TUBE in 1 CARTON (64980-302-30) > 28 g in 1 TUBE 1 tube 2012-06-01 0000-00-00 No No Current