doxycycline hyclate
- Product NDC
- 62135-984
- 11-digit product format
- 621350984
- Labeler code
- 62135
- Product ID
- 62135-984_40077986-5ebb-f8f0-e063-6394a90ad09f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxycycline hyclate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX LLC
- Application
- ANDA062500
- Marketing category
- ANDA
- Marketing start
- 1984-09-11
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- doxycycline hyclate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYCYCLINE HYCLATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N12000U13O, 19XTS3T51U |
| Rxcui | 1649405, 1649988, 1650030, 1650143, 1652674 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-984-05 | doxycycline hyclate | 500 in 1 BOTTLE | CAPSULE | 500 | | 16 |
| 62135-984-50 | doxycycline hyclate | 50 in 1 BOTTLE | CAPSULE | 50 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Doxycycline Hyclate | ACTIVE INGREDIENT | 19XTS3T51U | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| Doxycycline Anhydrous | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-984 | DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL RX LLC] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240402_3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62135-984-05 | 62135098405 | 500 CAPSULE in 1 BOTTLE (62135-984-05) | 500 capsule | 2022-02-17 | 0000-00-00 | No | No | Current |
| 62135-984-50 | 62135098450 | 50 CAPSULE in 1 BOTTLE (62135-984-50) | 50 capsule | 1984-09-11 | 0000-00-00 | No | No | Current |