Orphenadrine Citrate
- Product NDC
- 21695-099
- 11-digit product format
- 216950099
- Labeler code
- 21695
- Product ID
- 21695-099_34769dda-f555-460e-9064-98ab205393c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Orphenadrine Citrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040284
- Marketing category
- ANDA
- Marketing start
- 1998-06-19
- Marketing end
- 0000-00-00
- Substance
- ORPHENADRINE CITRATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-099-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d55-48b1-e053-8cdaa90a720a | Orphenadrine Citrate Extended-Release Tablets |
| 21695-099-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d55-48b1-e053-8cdaa90a720a | Orphenadrine Citrate Extended-Release Tablets |
| 21695-099-28 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d55-48b1-e053-8cdaa90a720a | Orphenadrine Citrate Extended-Release Tablets |
| 21695-099-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d55-48b1-e053-8cdaa90a720a | Orphenadrine Citrate Extended-Release Tablets |
| 21695-099-56 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d55-48b1-e053-8cdaa90a720a | Orphenadrine Citrate Extended-Release Tablets |
| 21695-099-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d55-48b1-e053-8cdaa90a720a | Orphenadrine Citrate Extended-Release Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-099-14 | Orphenadrine Citrate | 14 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 14 | 1 | |
| 21695-099-20 | Orphenadrine Citrate | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | 1 | |
| 21695-099-28 | Orphenadrine Citrate | 28 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 28 | 1 | |
| 21695-099-30 | Orphenadrine Citrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 1 | |
| 21695-099-56 | Orphenadrine Citrate | 56 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 56 | 1 | |
| 21695-099-60 | Orphenadrine Citrate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-099-14 | EA - Each | 21695-099 | 7b451341-2f3e-40c4-bc3b-1b2516a9c2a2 | 1 | 2012-07-24 |
| 21695-099-20 | EA - Each | 21695-099 | c340ed78-163e-4fe7-9299-916ee1ced3fc | 1 | 2012-07-24 |
| 21695-099-28 | EA - Each | 21695-099 | 0af48cf5-79a3-4e0c-a267-7f8ad1fa75fd | 1 | 2012-07-24 |
| 21695-099-30 | EA - Each | 21695-099 | f91b8791-432a-4579-8e2f-227c94621e14 | 1 | 2012-07-24 |
| 21695-099-56 | EA - Each | 21695-099 | ef6375d7-54ad-43ac-9979-c12652ae7eaa | 1 | 2012-07-24 |
| 21695-099-60 | EA - Each | 21695-099 | 029ca26b-8dda-4512-bc52-9c8a9347cac4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | ACTIVE INGREDIENT | X0A40N8I4S | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| ORPHENADRINE | ACTIVE MOIETY | AL805O9OG9 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 994521 | orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet | PSN | 34769dda-f555-460e-9064-98ab205393c5 | 1 |
| 994521 | 12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet | SCD | 34769dda-f555-460e-9064-98ab205393c5 | 1 |
| 994521 | orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet | SY | 34769dda-f555-460e-9064-98ab205393c5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-099-14 | 21695009914 | 14 in 1 BOTTLE | Historical |
| 21695-099-20 | 21695009920 | 20 in 1 BOTTLE | Historical |
| 21695-099-28 | 21695009928 | 28 in 1 BOTTLE | Historical |
| 21695-099-30 | 21695009930 | 30 in 1 BOTTLE | Historical |
| 21695-099-56 | 21695009956 | 56 in 1 BOTTLE | Historical |
| 21695-099-60 | 21695009960 | 60 in 1 BOTTLE | Historical |