Cyclopentolate Hydrochloride
- Product NDC
- 17478-100
- 11-digit product format
- 174780100
- Labeler code
- 17478
- Product ID
- 17478-100_ea22dcc7-ab6d-432b-a668-ac87777d0845
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclopentolate Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA040164
- Marketing category
- ANDA
- Marketing start
- 1997-01-13
- Marketing end
- 0000-00-00
- Substance
- CYCLOPENTOLATE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-100-02 | ML - Milliliter | 17478-100 | 03dfa6bc-6389-4d1a-a84f-e216c3968e35 | 1 | 2012-07-24 |
| 17478-100-12 | ML - Milliliter | 17478-100 | 290d9102-0e8b-4322-ad9c-9917263f2563 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1298066 | cyclopentolate HCl 1 % Ophthalmic Solution | PSN | c53c8090-921f-45c5-bcd1-ce156ae3bb28 | 4 |
| 1298066 | cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution | SCD | c53c8090-921f-45c5-bcd1-ce156ae3bb28 | 4 |
| 1298066 | cyclopentolate hydrochloride 1 % Ophthalmic Solution | SY | c53c8090-921f-45c5-bcd1-ce156ae3bb28 | 4 |
| 1298352 | AK-Pentolate 1 % Ophthalmic Solution | PSN | 1d97ba11-5b69-4ba3-9310-fa000183de43 | 1 |
| 1298066 | cyclopentolate HCl 1 % Ophthalmic Solution | PSN | 1d97ba11-5b69-4ba3-9310-fa000183de43 | 1 |
| 1298352 | cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [AK-Pentolate] | SBD | 1d97ba11-5b69-4ba3-9310-fa000183de43 | 1 |
| 1298066 | cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution | SCD | 1d97ba11-5b69-4ba3-9310-fa000183de43 | 1 |
| 1298352 | AK-Pentolate 1 % Ophthalmic Drops | SY | 1d97ba11-5b69-4ba3-9310-fa000183de43 | 1 |
| 1298352 | AK-Pentolate 10 MG/ML Ophthalmic Solution | SY | 1d97ba11-5b69-4ba3-9310-fa000183de43 | 1 |
| 1298066 | cyclopentolate hydrochloride 1 % Ophthalmic Solution | SY | 1d97ba11-5b69-4ba3-9310-fa000183de43 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17478-100-02 | 17478010002 | 1 BOTTLE, DROPPER in 1 CARTON (17478-100-02) > 2 mL in 1 BOTTLE, DROPPER | 1997-01-13 | 0000-00-00 | No | No | Current |
| 17478-100-10 | 17478010010 | 1 BOTTLE, DROPPER in 1 CARTON (17478-100-10) > 5 mL in 1 BOTTLE, DROPPER | 1997-01-13 | 0000-00-00 | No | No | Current |
| 17478-100-12 | 17478010012 | 1 BOTTLE, DROPPER in 1 CARTON (17478-100-12) > 15 mL in 1 BOTTLE, DROPPER | 1997-01-13 | 0000-00-00 | No | No | Current |