Home NDC 0054-0108 Ramipril
Product NDC 0054-0108
11-digit product format 000540108
Labeler code 0054
Product ID 0054-0108_4019e596-dfb9-43a4-b027-a2bdf6d0f5b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA077900
Marketing category ANDA
Marketing start 2008-06-18
Substance RAMIPRIL
Active strength 5 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077900-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 A077900-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 A077900-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 A077900-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077900-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077900-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077900-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077900-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ramipril
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RAMIPRIL 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L35JN3I7SJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198188 Internal RxNorm lookup 198189 Internal RxNorm lookup 261962 Internal RxNorm lookup 845488 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0108-20 Ramipril 10 in 1 CARTON CAPSULE 10 10 0054-0108-20 Ramipril 10 in 1 BLISTER PACK CAPSULE 10 10 0054-0108-25 Ramipril 100 in 1 BOTTLE CAPSULE 100 10 0054-0108-29 Ramipril 500 in 1 BOTTLE CAPSULE 500 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RAMIPRIL ACTIVE INGREDIENT L35JN3I7SJ RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 RAMIPRILAT ACTIVE MOIETY 6N5U4QFC3G RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RAMIPRIL CAPSULE [ROXANE LABORATORIES, INC] 4 RAMIPRIL ACTIVE INGREDIENT L35JN3I7SJ RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1 RAMIPRIL ACTIVE MOIETY L35JN3I7SJ RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RAMIPRIL CAPSULE [ATLANTIC BIOLOGICALS CORPS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0108 RAMIPRIL CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 4 package rows 20220121_7e9e84f7-ff47-463d-bf47-7a9745960aae.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0108-20 00054010820 10 BLISTER PACK in 1 CARTON (0054-0108-20) / 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2008-06-18 0000-00-00 No No Current 0054-0108-25 00054010825 100 CAPSULE in 1 BOTTLE (0054-0108-25) 100 capsule 2008-06-18 0000-00-00 No No Current 0054-0108-29 00054010829 500 CAPSULE in 1 BOTTLE (0054-0108-29) 500 capsule 2008-06-18 0000-00-00 No No Current