Home DailyMed a00fb96b-a729-4e34-9f7c-df4846da95cd National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:21:25 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 13 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020533-001 NAROPIN ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 N020533-002 NAROPIN ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 N020533-003 NAROPIN ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 N020533-004 NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 N020533-005 NAROPIN ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 N020533-006 NAROPIN ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 N020533-007 NAROPIN ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 N020533-008 NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 N020533-009 NAROPIN ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 N020533-010 NAROPIN ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 N020533-011 NAROPIN ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP RLD, RS 1996-09-24 N020533-012 NAROPIN ROPIVACAINE HYDROCHLORIDE 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1996-09-24 N020533-013 NAROPIN ROPIVACAINE HYDROCHLORIDE 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1998-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 11 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N020533-006 7857802 2026-11-28 Drug product 2014-11-06 N020533-007 7857802 2026-11-28 Drug product 2014-11-06
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 14 · 559 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 N020533-001 NAROPIN 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-002 NAROPIN 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-003 NAROPIN 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-004 NAROPIN 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-005 NAROPIN 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-006 NAROPIN 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-007 NAROPIN 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-008 NAROPIN 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-009 NAROPIN 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-010 NAROPIN 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-011 NAROPIN 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP RLD, RS 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-012 NAROPIN 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1996-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-013 NAROPIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1998-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020533-001 NAROPIN 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-002 NAROPIN 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-003 NAROPIN 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-004 NAROPIN 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-005 NAROPIN 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-006 NAROPIN 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-007 NAROPIN 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-008 NAROPIN 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-009 NAROPIN 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-010 NAROPIN 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-011 NAROPIN 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP RLD, RS 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-012 NAROPIN 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1996-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-013 NAROPIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1998-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020533-001 NAROPIN 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-002 NAROPIN 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-003 NAROPIN 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-004 NAROPIN 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-005 NAROPIN 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-006 NAROPIN 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-007 NAROPIN 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-008 NAROPIN 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP RLD 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-009 NAROPIN 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-010 NAROPIN 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP RLD 2011-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-011 NAROPIN 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP RLD, RS 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-012 NAROPIN 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1996-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-013 NAROPIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INJECTION RLD 1998-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020533-001 NAROPIN 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP RLD 1998-05-01 31067a03dcf5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 12 · 473 observed states.
Observed Orange Book patent history# Patent history page 1 of 8 · 282 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020533-006 7828787 2025-10-18 Drug product 2014-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020533-007 7828787 2025-10-18 Drug product 2014-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020533-006 7828787 2025-10-18 Drug product 2014-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020533-007 7828787 2025-10-18 Drug product 2014-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020533-006 7828787 2025-10-18 Drug product 2014-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020533-007 7828787 2025-10-18 Drug product 2014-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020533-006 7828787 2025-10-18 Drug product 2014-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020533-007 7828787 2025-10-18 Drug product 2014-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020533-006 8162915 2024-05-23 Drug product 2014-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020533-006 7828787 2025-10-18 Drug product 2014-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020533-007 8162915 2024-05-23 Drug product 2014-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020533-007 7828787 2025-10-18 Drug product 2014-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020533-006 8162915 2024-05-23 Drug product 2014-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020533-006 7828787 2025-10-18 Drug product 2014-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020533-007 8162915 2024-05-23 Drug product 2014-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020533-007 7828787 2025-10-18 Drug product 2014-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020533-006 8162915 2024-05-23 Drug product 2014-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020533-006 7828787 2025-10-18 Drug product 2014-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020533-006 7857802 2026-11-28 Drug product 2014-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020533-007 8162915 2024-05-23 Drug product 2014-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020533-007 7828787 2025-10-18 Drug product 2014-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020533-007 7857802 2026-11-28 Drug product 2014-11-06 5bbf6a4d5a75…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.