Cyclobenzaprine Hydrochloride
- Product NDC
- 85509-1035
- 11-digit product format
- 855091035
- Labeler code
- 85509
- Product ID
- 85509-1035_48c33f75-b43a-b007-e063-6394a90a411e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA091281
- Marketing category
- ANDA
- Marketing start
- 2019-03-01
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | |
| A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091281-001 | AB |
| A091281-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091281-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091281-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-01-31 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091281-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091281-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091281-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091281-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091281-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091281-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091281-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091281-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091281-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091281-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091281-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091281-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091281-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091281-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091281-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091281-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091281-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091281-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091281-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091281-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091281-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091281-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091281-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091281-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091281-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091281-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091281-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091281-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091281-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091281-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091281-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091281-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091281-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091281-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091281-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091281-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091281-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091281-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091281-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091281-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0VE05JYS2P | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 828358 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 48c33e51-db07-af68-e063-6294a90a897e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 51048710-225c-aa41-d0e7-eed095d02838 | Product name | 4 | 20250331 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| c2c26dc9-7e16-fc02-7eba-6b46ed3515ee | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85509-1035-3 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 1 | |
| 85509-1035-6 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | 1 | |
| 85509-1035-9 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 85509-1035-3 | EA - Each | 85509-1035 | 89c49231-1e8c-485e-89d5-cf115cedfb75 | 1 | 2026-02-05 |
| 85509-1035-6 | EA - Each | 85509-1035 | e52cfa42-920e-4c26-bc0c-488f4125a782 | 1 | 2026-02-05 |
| 85509-1035-9 | EA - Each | 85509-1035 | 4e2b6df8-8d08-4735-8f5e-3373d0c6a7d0 | 1 | 2026-02-05 |
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 |
|---|---|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 550d3e5a-c95f-4094-a500-1a02ea35a18d | 2026-04-01 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | fada6577-bcb8-422c-be37-08562919ebc9 | 2026-03-30 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PHOENIX RX LLC | 48c33e51-db07-af68-e063-6294a90a897e | 2026-01-19 | Warnings, Adverse reactions | 091281 ANDA091281 85509-1035 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | ba659e1a-0091-45f6-b418-f4f36c9a2c79 | 2025-09-30 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 14f64ceb-ea5c-4d7c-a0c1-3f6a64847290 | 2025-02-20 | Warnings, Adverse reactions | 091281 ANDA091281 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | a512d34c-8164-0c04-e053-2995a90a1942 | 2025-01-17 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 3dd2bde1-f06d-493a-91c7-22b28a5e1699 | 2025-01-07 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2998c9e6-2f60-ef35-e063-6394a90a7bc7 | 2024-12-18 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | bfdd9460-5dfa-4588-8f4f-9d227c1717d5 | 2024-10-24 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | d8112916-28ae-452c-8ec8-a4972e5f549b | 2022-05-02 | Warnings, Adverse reactions | 091281 ANDA091281 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | ffd82a69-a64c-4399-8f5d-bddc70cdc3cf | 2022-05-01 | Warnings, Adverse reactions | 091281 ANDA091281 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 828358 | cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule | PSN | 48c33e51-db07-af68-e063-6294a90a897e | 1 |
| 828358 | 24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule | SCD | 48c33e51-db07-af68-e063-6294a90a897e | 1 |
| 828358 | cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule | SY | 48c33e51-db07-af68-e063-6294a90a897e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85509-1035-3 | 85509103503 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-3) | 2026-01-19 | No | No | Current |
| 85509-1035-6 | 85509103506 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-6) | 2026-01-19 | No | No | Current |
| 85509-1035-9 | 85509103509 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-9) | 2026-01-19 | No | No | Current |