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 02:29:58

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-211-10EA - Each59746-211b2c656ef-252b-41d6-a6ef-958f9fb0f91f12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59746-21159746-211-10

Source Document#

Source XML

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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077563-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19
A077563-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19
A077563-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077563-001AB
A077563-002AB
A077563-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2584e616aacf4f…
2026-08-18 06:07:402026-07A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077563-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077563-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077563-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077563-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077563-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077563-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077563-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077563-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077563-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-001AB1301d65b070ca…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.592871f6-0eb2-4624-9e10-bd8bf767c0022025-02-21Warnings, Adverse reactionsExact identifier
ndc (package): 59746-211-10
ndc11 (package): 59746021110

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.