Home NDC 65862-477-01 Ramipril
Product NDC 65862-477
Requested package NDC 65862-477-01
11-digit product format 658620477
Labeler code 65862
Product ID 65862-477_128ba879-8a6e-4d23-94af-ad958a8d981b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA091604
Marketing category ANDA
Marketing start 2011-06-08
Substance RAMIPRIL
Active strength 10 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091604-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 A091604-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 A091604-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 A091604-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08
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 · 172 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 2026-09-14 22:38:34 2026-08 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 Ramipril
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RAMIPRIL 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RAMIPRIL ACTIVE INGREDIENT L35JN3I7SJ RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 RAMIPRILAT ACTIVE MOIETY 6N5U4QFC3G RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 GELATIN INACTIVE INGREDIENT 2G86QN327L RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 SHELLAC INACTIVE INGREDIENT 46N107B71O RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 10 RAMIPRIL ACTIVE INGREDIENT L35JN3I7SJ RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 RAMIPRILAT ACTIVE MOIETY 6N5U4QFC3G RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.] 2 RAMIPRIL ACTIVE INGREDIENT L35JN3I7SJ RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 RAMIPRILAT ACTIVE MOIETY 6N5U4QFC3G RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-477 RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED] 17 Current NDC, Legacy NDC, 6 package rows 20240426_d6d57158-e8f9-4c91-8317-0374e0c87d33.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 2 of 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ramipril RAMIPRIL Proficient Rx LP d3513b8b-2d8a-456d-b942-a25ec1965b04 2019-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091604 application number: ANDA091604
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 65862-477-01 65862047701 100 CAPSULE in 1 BOTTLE (65862-477-01) 100 capsule 2011-06-08 0000-00-00 No No Current