National Council for Prescription Drug Programs indexing - billing unit
- 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 02:51:20
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-1582-10 | ML - Milliliter | 0409-1582 | d75db1c5-e4eb-4583-b73d-3304c77abb50 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0409-1582 | 0409-1582-10 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016964-001 | MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-006 | MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N016964-001 | AP |
| N016964-004 | AP |
| N016964-005 | AP |
| N016964-006 | AP |
| N016964-007 | AP |
| N016964-008 | AP |
| N016964-009 | AP |
| N016964-010 | AP |
| N016964-012 | AP |
| N016964-013 | AP |
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.
| 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 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-001 | MARCAINE HYDROCHLORIDE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-004 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-005 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-006 | MARCAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-007 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-008 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | 0.5%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-009 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.75% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-010 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.75%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-012 | MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | 0.25% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-013 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 0.25%;0.0091MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016964-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-004 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-005 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-006 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-007 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-008 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-009 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-010 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-012 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016964-013 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-005 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-006 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-007 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-008 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-009 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-010 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-012 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016964-013 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-006 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-007 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-008 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-009 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-010 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-012 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016964-013 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-006 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-007 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-008 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-009 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-010 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-012 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016964-013 | AP | 1 | 31067a03dcf5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Marcaine | BUPIVACAINE HYDROCHLORIDE | Hospira, Inc. | 67578b56-7540-487e-1fba-481255620e78 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 0409-1582-10 00409158210 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.